# J.R. Simplot Company Petition ( 13

- 022

- 01p ) for Determination of Non

- R egulated Status for InnateTM Potatoes with Low Acrylamide Potential and Reduced Black Spot Bruise: Events E12 and E24 (Russet Burbank); F10 and F37 (Ranger Russet); J3, J55, and J78 (Atlantic); G11 (G); H37 and H50 (H)

OECD Unique Identifiers: SPS

- 00F10

- 7 ; SPS

- 00F37

- 7 ;
SPS

- 0E12

- 8 ; SPS

- 00E24

- 2 ; SPS

- 000J3

- 4 ; SPS

- 00J55

- 2 ;
SPS

- 00J78

- 7 ; SPS

- 00G11

- 9 ; SPS

- 00H37

- 9 ; SPS

- 00H50

- 4



# Final Environmental Assessment

July 2014
Agency Contact
Cindy Eck Biotechnology Regulatory Services
4700 River Road
USDA, APHIS Riverdale, MD 20737 Fax: (301) 734

- 8669

iThe U.S. Department of Agriculture (USDA) prohibits discrimination in all its programs and activities on the basis of race, color, national origin, sex, religion, age, disability, political beliefs, sexual orientation, or marital or family sta tus. (Not all prohibited bases apply to all programs.) Persons with disabilities who require alternative means for communication of program information (Braille, large print, audiotape, etc.) should contact USDA’S TARGET Center at (202) 720

– 2600 (voice and TDD).

To fi le a complaint of discrimination, write USDA, Director, Office of Civil Rights, Room 326

– W, Whitten Building, 1400 Independence Avenue, SW, Washington, DC 20250

– 9410 or call (202) 720

– 5964 (voice and TDD). USDA is an equal opportunity provider and employer

.

Mention of companies or commercial products in this report does not imply recommendation or endorsement by the U.S. Department of Agriculture over others not mentioned. USDA neither guarantees nor warrants the standard of any product mentioned. Produc t names are mentioned solely to report factually on available data and to provide specific information.

This publication reports research involving pesticides. All uses of pesticides must be registered by appropriate State and/or Federal agencies befor e they can be recommended.

ii

## TABLE OF CONTENTS PAGE

LIST OF FIGURES

................................ ................................ ................................ ........................ vii

LIST OF TABLES

................................ ................................ ................................ .......................... vii

ACRONYMS AND ABBREVIATIONS

................................ ................................ ........................... viii

1 PURPOSE AND NEED

................................ ................................ ................................ ............... 1
1.1 Background

................................ ................................ ................................ ........................... 1

1.1.1 The APHIS Regulatory Authority

................................ ................................ .............. 1

1.1.2 Purpose of this Product

................................ ................................ ............................ 2
1.2 Coordinated Regulatory Framework for Genetically

- Engineered Organisms

...................... 3

1.2.1 USDA

- APHIS

................................ ................................ ................................ .................... 3
1.2.2 Environmental Protection Agency

................................ ................................ .................. 4
1.2.3 Food and Drug Administrat ion

................................ ................................ ....................... 5
1.3 Purpose and Need for This APHIS Action

................................ ................................ .............. 5

1.3.1 Public Involvement

................................ ................................ ................................ ......... 6
1.3.2 Public Involvement Approach for This EA

................................ ................................ ...... 7

1.4 Iss ues Considered

................................ ................................ ................................ .................. 9

2 AFFECTED ENVIRONMENT

................................ ................................ ................................ .... 11
2.1 Agricultural Production and Agronomic Practices of Potato

................................ .............. 11

2.1.1 Land Use

................................ ................................ ................................ ....................... 11

2.1 .2 General Agronomic Practices

................................ ................................ ....................... 15
2.2 Physical Environment

................................ ................................ ................................ .......... 24

2.2.1 W ater Resources

................................ ................................ ................................ .......... 24
2.2.2 Soil Quality

................................ ................................ ................................ .................... 26
2.2.3 Air Quality

................................ ................................ ................................ ..................... 27

iii

## TABLE OF CONTENTS (Continued) PAGE

2.2.4 Climate Change

................................ ................................ ................................ ............ 28
2.3 Biological Resources

................................ ................................ ................................ ............ 29

2.3.1 Animal Communities

................................ ................................ ................................ .... 29

2.3.2 Plant Communities

................................ ................................ ................................ ....... 30

2.3.3 Gene Flow and Weediness

................................ ................................ ........................... 30
2.3.4 Microorganisms

................................ ................................ ................................ ............ 32
2.3.5 Biodiversity

................................ ................................ ................................ ................... 33

2.4 Human and Animal Health

................................ ................................ ................................ .. 34

2.4.1 Consumer Health

................................ ................................ ................................ .......... 34

2.4.2 Worker Health

................................ ................................ ................................ .............. 37

2.4.3 Animal Feed

................................ ................................ ................................ .................. 37

2.5 Socioeconomics

................................ ................................ ................................ ................... 39

2.5.1 Domestic Economic Environment

................................ ................................ ................ 40

2.5.2 Trade Economic Environment

................................ ................................ ...................... 43
2.5.3 Organically Certified Economic Environment

................................ .............................. 44

3. ALTERNATIVES

................................ ................................ ................................ ............................ 46
3.1 No Action Alternative: Continuation as a Regulated Article

................................ .............. 46

3.2 Preferred Alternative: Det ermination That Simplot InnateTM Potato Is No Longer a Regulated Article

................................ ................................ ................................ ............................ 46
3.3 Alternatives Considered But Rejected from Further Consideration

................................ ... 46
3.3.1 Prohibit Any Simplot InnateTM Potato from Being Released

................................ ........ 47
3.3.2 Approve the Petition in Part

................................ ................................ ......................... 47
3.3.3 Isolation Distance between Simplot InnateTM Potato and Non

- GE Potato Production and Geographical Restrictions

................................ ................................ ............... 47
3.3.4 Requirement of Testing for Simplot InnateTM Potato

................................ ................... 48
3.4 Comparison of Alternatives

................................ ................................ ................................ 48 iv

## TABLE OF CONTENTS (Continued) PAGE

4 ENVIRONMENTAL CONS EQUENCES

................................ ................................ ............................ 54
4.1 Environmental Consequences

................................ ................................ ............................. 54
4.2 Scope of Analysis

................................ ................................ ................................ ................. 54
4.3 Agricultural Production of Potato

................................ ................................ ....................... 55
4.3.1 Acreage and Area of Potato Production

................................ ................................ ...... 55
4.3.2 Agronomic Practic es

................................ ................................ ................................ ..... 56

4.3.3 Potato Seed Production

................................ ................................ ............................... 57
4.3.4 Organic Potato Production

................................ ................................ ........................... 57
4.4 Physical Environment

................................ ................................ ................................ .......... 58

4.4.1 Water Resources

................................ ................................ ................................ .......... 58
4.4.2 Soil Quality

................................ ................................ ................................ .................... 59
4.4.3 Air Quality

................................ ................................ ................................ ..................... 59
4.4.4 Climate Change

................................ ................................ ................................ ............ 60
4.5. Biological Resources

................................ ................................ ................................ ........... 60

4.5.1 Animal Communities

................................ ................................ ................................ .... 60

4.5.2 Plant Communities

................................ ................................ ................................ ....... 64

4.5.3 Gene Flow and Weediness

................................ ................................ ........................... 64
4.5.4 Microorganisms

................................ ................................ ................................ ............ 65
4.4.5 Biodiversity

................................ ................................ ................................ ................... 65

4.6 Human and Animal Health

................................ ................................ ................................ .. 66

4.6.1 Human Health

................................ ................................ ................................ .............. 66
4.6.2 Worker Safety

................................ ................................ ................................ ............... 67

4.6.3 Animal Feed

................................ ................................ ................................ .................. 68
4.7 Socioeconomic Impacts

................................ ................................ ................................ ...... 69

4.7.1 Domestic Economic Environment

................................ ................................ ................ 69

v

## TABLE OF CONTENTS (Continued) PAGE

4.7.2 Trade Economic Environment

................................ ................................ ...................... 70

5 CUMULATIVE IMPACTS

................................ ................................ ................................ ......... 72
5.1 Assumptions Used for Cumulative Impacts Analysis

................................ .......................... 72
5.2 Past and Present and Reasonably Foreseeable Actions

................................ ..................... 73

6 THREATENED AND ENDAN GERED SPECIES

................................ ................................ ........... 77
6.1 Potential Effects of Simplot InnateTM Potato on TES and Critical Habitat

..................... 80

7 CONSIDERATION OF EXE CUTIVE ORDERS, STAND ARDS, AND TREATIES R ELATING TO ENVIRONMENTAL IMPACT S

................................ ................................ ................................ . 85
7.1 Executive Orders with Domestic Implications

................................ ................................ .... 85
7.2 International Implications

................................ ................................ ................................ ... 88
7.3 Compliance with Clean Water Act and Clean Air Act

................................ .......................... 89
7.4 Impacts on Unique Characteristics of Geographic Areas

................................ .................... 89
7.5 Impacts on Unique Characteristics of Geographic Areas

................................ .................... 90
7.6 National Historic Preservation Act (NHPA) of 1966 as Amended

................................ ....... 90

8 REFERENCES

................................ ................................ ................................ .......................... 92

viLIST OF FIGURES
Figure 1. Potato Growing Regions of the United States (USDA

- NASS, 2007)

................................ ............ 12

LIST OF TABLES

Table 1. Major Potato Production States

................................ ................................ ................................ .... 13

Table 2. U.S. 2012 Potato Harvest by State

................................ ................................ .............................. 14
Table 3. Major Insect Pests of Potato

................................ ................................ ................................ ........ 18
Table 4. Major Diseases of Potato

................................ ................................ ................................ ............. 19
Table 5. Major Weeds of Potato

................................ ................................ ................................ ................ 21
Table 6. U.S. Per Capita Potato Consumption 2011

................................ ................................ ................... 34

Table 7. U.S. 2012 Potato Utilization

................................ ................................ ................................ ......... 38

Table 8. A Sample of U.S. Potato Varieties and their U ses

................................ ................................ ........ 40

Table 9. Summary of Issues of Potential Impacts and Consequences of Alternatives

.............................. 48

viiACRONYMS AND ABBREVIATIONS



### AMS Agricultural Marketing Service (within USDA)
AOSCA American Organization of Seed Certifying Agencies
APHIS Animal and Plant Health Inspection Service (within USDA AMS)
BRS Biotechnology Regulatory Services (within USDA

– APHIS)
CAA Clean Air Act
CBD Convention on Biological Diversity CEQ Council on Environmental Quality
CFR Code of Federal Regulations (United States)
CH 4 

### M ethane
CO c arbon monoxide
CO 2 

### c arbon dioxide
CWA DNA Clean Water Act deoxyribonucleic a cid
EA e nvironmental a ssessment
EIS e nvironmental i mpact s tatement
EO Executive O rder
EPA U.S. Environmental Protection Agency
ESA Endangered Species Act of 1973
FDA U.S. Food and Drug Administration
FFDCA Federal Food, Drug, and Cosmetic Act
FFP f ood, feed, or processing
FIFRA FONSI FQPA Federal Insecticide, Fungicide , and Rodenticide Act Finding of No Significant Impact Food Quality Protection Act

viiiACRONYMS AND ABBREVIATIONS



### FR FWS Federal Register Fish and Wildlife Service (of the U.S)
GE g enetically e ngineered

GHG 

### g reenhouse gas

IPM IPPC Integrated Pest Management
International Plant Protection Convention
ISPM International Standard for Phytosanitary Measure s LMO
M NGO living modified organism
Million

non

- government organization
NO 2 

### n itrogen dioxide
N 2 

### O n itrous oxide NAAQS National Ambient Air Quality Standards
NABI North American Biotechnology Initiative
NAPPO North American Plant Protection Organization
NEPA National Environmental Policy Act ( of 1969 and subsequent amendments )
NHPA
NMFS
NOP NPS
NRC NRCS
PIP
PM
PPA National Historic Preservation Act
National Marine Fisheries Service National Organic Program (of USDA AMS)

non

- point source
National Research Council
Natural Resources Conservation Service
Plant

- incorporated protectants
Particulate matter
Plant Protection Act

ixACRONYMS AND ABBREVIATIONS



### PPM
PPRA
RNA SSA
TES
TPS
U.S.
USDA
USDA

- ERS
USDA

- FAS
USDA

- NASS
USDA

- NOP
WPS parts per million
Plant Pest Risk Assessment

r ibonucleic acid sole source aquifer threatened and endangered species true potato seed
United States U.S. Department of Agriculture U.S. Department of Agriculture

- Economic Research Service U.S. Department of Agriculture

- Foreign Agricultu ral Service U.S. Department of Agriculture

- National Agricultural Statistics Service U.S. Department of Agriculture

- National Organic Program Worker Protection Standard (for agricultural pesticides)

x1 PURPOSE AND NEED

1.1 Background
J.R. Simplot 1 of Boise, Idaho, submitted petition 13

- 022

- 01p to the United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) in March 2013 , seeking a determination of nonregulated status for Simplot Innate TM p otato genetically engineered (GE) with low acrylamide potential and reduced black spot bruise (events E12 and E24 (Russet Burbank); F10 and F37 (Ranger Russet); J3, J55, and J78 (Atlantic); G11 (G); and H37 and H50 (H)). The petitio n was deemed complete by APHIS o n March 22, 2013. Simplot InnateTM p otato is currently regulated under 7 CFR part 340. Interstate movements and field trials of Simplot InnateTM p otato have been conducted under permits issued or notifications acknowledged by APHI S since 2009. These field trials were conducted in Florida, Indiana, Idaho, Michigan, Nebraska, North Dakota, Washington, and Wisconsin. Data resulting from these fi eld trials are similar to data requirements for other petitions submitted to APHIS and de scribed in Simplot’s InnateTM p otato petition ( Simplot, 2013b ) and analyzed for plant pest risk in the APHIS Plant Pest Risk Assessment (PPRA) ( USDA

- APHIS, 2013a )

. Data from field trials is analyzed and evaluated in ways that assess treatment differences and statistically account for biological variation

. The petition stated that APHIS should not regulate Simplot InnateTM p otato because it does not present a plant pest risk. In the event of a determination of nonregulated status, the nonregulated status would include Simplot InnateTM p otato , any progeny derived from crosses between Simplot InnateTM p otato and conventional potato , and crosses of Simplot InnateTM p otato with ot her biotechnology

- derived potatoes that are no longer subject to the regulatory requiremen ts of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act.

1.1.1 The APHIS Regulatory Authority
The Plant Protection Act ( PPA ) authorizes and mandates APHIS to regulate, manage and control plant pests. This directive includes regulatory au thority over the introduction (i.e., importation, interstate movement, or release into the environment) of certain GE organisms and products. A GE organism is no longer subject to the plant pest provisions of the PPA or to the regulatory requirements of 7 CFR part 340, when APHIS determines that it is unlikely to pose a plant pest risk. A GE organism is considered a regulated article if the donor organism, recipient organism, vector, or vector agent used in engineering the organism belongs to one of the t axa listed in the regulation (7 CFR 340.2) and is also considered a plant pest. A GE organism is also regulated under 7 CFR 340 when APHIS has reason to believe that the GE organism may be a plant pest, or APHIS does not have information to determine if the GE organism is unlikely to pose a plant pest risk.

1 Referred to as the JR Simplot Company or Simplot hereinafter

1A person may petition the agency for a determination that a particular reg ulated article is unlikely to pose a plant pest risk, and therefore, is no longer regulated under the plant pest provisions of the PPA or the regulations at 7 CFR 340. Under § 340.6(c)(4), the petitioner must provide information related to plant pest risk that the agency can use to determine whether the regulated article is unlikely to present a plant pest risk. A GE organism is no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the PPA when APHIS determines that it is unlikely to pose a plant pest risk.

1.1.2 Purpose of this Product
Simplot InnateTM p otato is genetically engineered to exhibit low acrylamide potential in cooked potatoes and reduced black spot bruise. Acrylamide is a human neurotoxicant and potential carcinogen th at may form in potatoes and other starchy foods under high

- temperature cooking conditions 2 . Black spot bruise is a post

- harvest physiological disorder primarily resulting from the handling of potato tubers during harvest, transport , and proc essing, and refers to the black or grayish color which may form in the interior of damaged potatoes

. The 10 Simplot InnateTM p otato events were produced by using Agrobacterium

- mediated transformation of potato internode explants of 5 different varieties: Ranger Russet, Russet Burbank, Atlantic, variety G and variety H ( Sim plot, 2013b ) . The binary plas mid vector pSIM1278 ( Simplot, 2013b ) , consisting of the vector bac kbone ( Simplot, 20 13b ) and th e DNA insert ( Simplot, 2013b ) was used to create all 10 events; only the DNA insert portion was intended to be transferred to the recipient plants. The DNA insert in plasmid pS 2 IM1278 is designed to silence four different genes in the potato: asparagine synthetase

- 1 ( Asn1 ), polyphenol oxidase

- 5 ( Ppo5 ), pota to phosphorylase L ( PhL ) and the starch

- associated R1 gene ( R1 ). The suppression of Asn1 is anticipated t o result in potatoes with reduced free asparagine, and the suppression of PhL and R1 is anticipated to result in potatoes with a lower content of redu cing sugars. The gene targets of these four silencing constructs have been well

- studied in potato and/or other plant species (Simplot, 2013a; USDA

- APHIS, 2013a). Collectively, the silencing of these 3 genes should result in potato tubers with a reduced a crylamide potential. The suppression of Ppo5 confers the Simplot InnateTM potato with a non

- browning phenotype resulting in tubers with reduced black spot bruising. Black spot bruise can lead to economic losses as high as 20 % ( Partington et al. , 1999 ) ; the potato industry therefore has a vested interest in minimizing these losses. Bachem et al. ( 1994 ) demonstrated that black spot bruise can be reduced by silencing Ppo genes in potatoes, and Simplot has further developed this concept in the design of Simplot InnateTM potato ( Simplot, 2013b )

. The intended purpose of the 10 Simplot InnateTM potato lines is to provide the potato processing industry with new varieties with low acrylamide potential and reduced black spot bruise. Both of these changes are intended to benefit potato consumers, produc ers, and processors. The low acrylamide

2 e.g., frying

2potential is intended to benefit consumers because of concerns about the health effects of ingesting acrylamide ( FDA, 2013b )

. Simplot InnateTM potatoes may offer an efficient method to reduce acrylamide in the diet. The reduced black spot bruise trait is intended to benefit consumers by provi ding a higher quality product, to benefit producers by reducing culls at delivery, and to benefit processors by reducing wastag e

. Simplot InnateTM potato tubers are nutritionally and compositionally similar to their respective parental varieties and/or other commercial potato varieties, with the exception of the intentional changes conferred by the introduced genes. These intentio nal changes fall into three broad categories: (1) reduction of PPO enzyme levels in tubers; (2) alteration of the levels of asparagine and glutamine in the pool of free amino acids in tubers; and (3) reduction in the levels of the reducing sugars glucose a nd fructose in tubers (USDA

- APHIS, 2013a)

.
1.2 Coordinated Regulatory Framework for Genetically

- Engineered Organisms

The U.S. government has regulated GE organisms since 1986 under Federal regulations published in the Federal Register ( 51 FR 23302 ; 57 FR 22984 ) entitled “ The Coordinated Framework for the Regulation of Biotechnology ” ( henceforth referred to here as the Coordinated Framework). The Coordinated Framework, publishe d by the Office of Science and Technology Polic y, describes the comprehensive F ederal regulatory policy for ensuring the safety of biotechnology research and products . It also explains how F ederal agencies will use existing Federal statutes to ensure publ ic health and environmental safety while maintaining regulatory flexibility to avoid impeding the growth of the biotechnology industry. The Coordinated Framework is based on several important guiding principles: (1) agencies should define those transgenic organisms subject to review to the extent permitted by their respective statutory authorities; (2) agencies are required to focus on the characteristics and risks of the biotechnology product, not the process by which it was created; (3) agencies are mand ated to exercise oversight of GE organisms only when there is evidence of “unreasonable” risk.
The Coordinated Framework explains the regulatory roles and authorities for the three major agencies involved in regulating GE organisms: USDA APHIS, the Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA). A summa ry of each role follows.

1. 2

. 1 USDA

- APHIS
APHIS regulations at 7 Code of Federal Regulations (CFR) part 340, which were promulgated pursuant to authority granted by the PPA, as amended (7 United States Code (U.S.C.) 7701

– 7772), regulate the introduction (importation, interstate movement, or release into the environment) of certain GE organisms and products. A GE organism is no longer subject to the plant pest provisi ons of the PPA or to the regulatory requirements of 7 CFR part 340 when APHIS determines that it is unlikely to pose a plant pest risk. A GE organism is considered a regulated article if the donor organism, recipient organism, vector, or vector agent used in engineering the organism belongs to one of the taxa listed in the regulation (7 CFR 340.2) and is also considered a plant pest. A GE organism is also regulated under Part

3340 when APHIS has reason to believe that the GE organism may be a plant pest or APHIS does not have information to determine if the GE organism is unlikely to pose a plant pest risk.
A person may petition the agency for a determination that a particular regulated article is unlikely to pose a plant pest risk, and, therefore, is no lo nger regulated under the plant pest provisions of the PPA or the regulations at 7 CFR 340. Under § 340.6(c)(4), the petitioner must provide information related to plant pest risk that the agency may use to determine whether the regulated article is unlike ly to pose a plant pest risk. A GE organism is no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the PPA when APHIS determines that it is unlikely to pose a plant pest risk.

1. 2 .2 Environmental Protection A gency
The EPA is responsible for regulating the sale, distribution, and use of pesticides, including those that are expressed by an organism modified using techniques of modern biotechnology. Such pesticides are regulated by EPA as plant

- incorporated prot ectants (PIPs) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136 et seq. ) . EPA also regulates certain biological control organisms under th e Toxic Substances Control Act (15 U.S.C. 53 et seq .). Before planting a crop con taining a PIP, a company must seek an experimental use permit from EPA. Commercial production of crops containing PIPs for purposes of seed increase and sale requires a FIFRA Section 3 registration with EPA.
Under FIFRA (7 U.S.C. 136 et seq. ), EPA requir es registration of all pesticide products for a ll specific use s prior to distribution f or sale. Before granting a registration, EPA evaluates the toxicity of the ingredients of pesticide product ; the particular site or crop on which it is to be used; the amount, frequency, and timing of its use; storage and disposal requirements . Prior to registration for a new use for a new or previously registered pesticide, EPA must determine through testing that the pesticide does n ot cause unreasonable adverse effects on humans, the environment, and non

- target species , when used in accordance with label instructions. EPA must also approve the language used on the pesticide label in accordance with 40 CFR pa rt 158. Once registered, a pesticide may only be legally used in accordance with directions and restrictions on its label. The purpose of the label is to provide clear directions for effective product performance , while minimizing risks to human health a nd the environment. The Food Quality Protection Act (FQPA) of 1996 amended FIFRA, enabling EPA to implement periodic registration review of pesticides to ensure they are meeting current scientific and regulatory standards of safety and continue to have no unreasonable adverse effects ( US

- EPA, 2011d )

. EPA also sets tolerances (maximum residue levels) or establishes an exemption from the requirement for a tolerance, under the Federal Food, Drug, and Cosmetic Act (FFDCA). A tolerance is the amount of pesticide residue that can remain on or in food for human consumption or animal feed . B efore establishing a pesticide tolerance, EPA is required to reach a safety determination based on a finding of reasonable certainty of no harm under the FFDCA, as amended by the FQPA. FDA enfo rces the pesticide tolerances set by EPA.

4The ten Simplot InnateTM p otato events are not engineered to express substances to pro tect the potatoes against plant pests, and are therefore not subject to EPA review.

1. 2 .3 Food and Drug Administration
FDA regulates GE organisms under the authority of the FFDCA (21 U.S.C. 301 et seq. ). The FDA published its policy statement concerning regulation of products derived from new plant varieties, including those deriv ed from genetic engineering, on May 29, 199 2 ( 57 FR 22984 ) . Under this policy, FDA implements a voluntary consultation process to ensure that human food and animal feed safety issues or other regulatory i ssues, such as labeling, are resolved before commercial distribution of food derived from GE products . This voluntary consultation process provides a way for developers to receive assistance from FDA in complying with their obligations under Federal food safety laws prior to marketing.
In June 2006, FDA published recommendations in “Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non

- Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use ” ( US

- FDA, 2006 )

. This establishes voluntary food safety evaluations for new non

- pesticidal proteins produced by new plant varieties intended to be used as food, including GE plants. Early food safety evaluations help make sure that potential food safety issues related to a new protein in a new plant variety are addressed early in development. These evaluations are not intended as a replacement for a biotechnology consultation with FDA, but the information may be used later in the biotechnology consultation.
The J.R. Simplot Company submitted a letter of consultation on February 12, 2013, which FDA is still reviewing (BNF No. 141).

1.3 Purpose and Need for This APHIS Action
APHIS respond s to petitioners that request a determination of the regulated status of GE organisms (7 CFR 340.6) , including GE p lants such as Simplot Innate TM p otato . When a petition for nonregulated status is submitted, APHIS determine s if the GE organism poses a plant pest risk. Under § 340.6(c)(4) , the petitioner is required to provide information related to plant pest risk that the agency may use to determine w hether the r egulated article is unlikely to pose a plant pest risk. A GE organism is no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the PPA when APHIS determines that it is unlikely to pose a plant pest risk.
In this EA, APHIS is respond ing to a petition from Simplot requesting a determination of nonregulated status for Simplot InnateTM p otato . AP HIS consi der s the potential environmental effects of an agency determination of nonregulated status of Simplot InnateTM p otato consistent with regulations for implementing the National Environmental Policy Act (NEPA ; 40 CFR parts 1500

- 1508 ) , and the APHIS NEPA

- implementing regulations and procedures (7 CFR part 1b, and 7 CFR part 372). This EA specifically evaluate s the effects on the quality of the human environment that may result from a determination of nonregulated status for Simplot InnateTM p otato

.

51. 3 .1 Public Involvement
APHIS routinely seeks public comment on EAs prepared in response to petitions see king a determination of nonregulated status of a regulated GE organism

. APHIS does this through a notice published in the Federal Register

. Through a March 6, 2012 notice published in the Federal Register 3
, APHIS implement ed changes to the way it solicits public comment when considering petitions for determinations of nonregulated status for GE organisms . The purpose of this change was to allow early public involvement in the process

. As identified in this notice , APHIS pub lish es two separate notices in the Federal Register for petitions for which APHIS prepares an EA. The first notice announce s t he availability of the petition; the second announce s the availability of the APHIS decision

- making documents. The new process a llows for public involvement by establishing a comment period after each of the two notices published in the Federal Register

.

First Opportunity for Public Involvement:

Once APHIS judges a petition complete, a 60

- day comment period is established for the public to submit comments to assist the Agency in the development of it EA and PPRA. Th e availability of the petition for public comment is announced in a Federal Register notice.

Second Opportunity for Public Involvement

T he draft PPRA and draft EA are developed , and a notice of their availability is published in a second Federal Register notice. This second notice follows one of two approaches for public participation based on whether or not APHIS de te rmines the petition for nonregulated status for a GE organism involves substantive new issues:
Approach 1 . For GE organisms that do not involve substantive new issues

T his is used when APHIS de termines , based on a review of the petition and its evaluation and analysis of public submissions received during the 60

- day commen t period for the petition, that the GE organism does not involve new biological, cultural, or ecological issues

. Agency criteria for this decision include a determination that the nature of the modification is not novel or th at the Agency has a high degree of familiarity with the organism through previous regulatory actions , or both

. After this determination is

3 This notice can be accessed at: http://www.gpo.gov/fdsys/pkg/FR

- 2012

- 03

- 06/pdf/2012

- 5364.pdf

6made, APHIS conducts the necessary analysis and prepares its PPRA, EA, and finding of no significant impact (FONSI) . Once completed, APHIS publish es a notice in the Federal Register announcing its preliminary regulatory determination and the availability of the EA, FONSI, and PPRA for a 30

- day public review and comment period.

Unless information received in public comments warrant s substantially changing the PPRA or EA analysis and determination, the Agency’s preliminary regulatory determination become s effective . No further Federal Register notices are published announcing the final regulatory determination. The Agency post s this public notification in an announcement on the APHIS website.
Approach 2. For GE organisms involving substantive new issues not previously analyzed
This pro tocol is used when a petition is for nonregulated status for a novel GE organism . A novel organism is one that is not identical with or sufficiently similar to organisms determined previously by APHIS to have nonregulated status

. Examples include organisms w ith new gene modifications that could have substantial biological, cultural, or ecological effects not previously analyzed. For this process, APHIS prepares draft s of a PPRA and an EA , and then solicits further comments during a 30

- day period that is announced in a Federal Register notice. APHIS review s and evaluate s comments and other relevant information . APHIS then revise s the PPRA as necessary and prepare s a final EA. Following preparation of these documents, APHIS approve s or den ies the petitio n, then announces its decision in the Federal Register , and provides notice of the availability of the final EA, PPRA, NEPA decision document, and regulatory determination.
More details about this expansion of opportunities for stakeholder review and comme nt are available in the Federal Register notice published on March 6, 2012 4

.
1. 3 .2 Public Involvement Approach for This EA

APHIS has de termined that the protocol for preparation of this EA will follow Approach 2. The issues considered in this EA were developed by reviewing the public concerns, including public comments received in response to the Federal Register notice on May 3, 2013 ( 78 FR 25942

- 25943 ) announcing the availability of the petition ( i.e., the first oppor tunity for public involvement previously described in this document ) . The Agency also considered public comments submitted for other EAs of GE organisms, and

concerns described in lawsuits or expressed by various stakeholders. These issues, including those regarding the agricultural production of Simplot InnateTM p otato using various production methods and the environmental and food/feed safety of GE plants , were addressed to analyze the potential environmental impacts of Simplot InnateTM p otato

.

4 This notice can be accessed at: http://www.gpo.gov/fdsys/pkg/FR

- 2012

- 03

- 06/pdf/2012

- 5364.pdf

7T he public comment period f or the review of this petition for nonregu la tory status of Simplot Innate TM p otato closed on July 2, 2013

. At its closing, the docket file contained a total of 308 public comments

. Th ese were screened and sorted into categories according to the subject matter addressed (e.g., air, water, soil impact s) , and classified as either non

- substantive or substantive. Most of the comments that expressed a general dislike of the use of GE organisms were considered non
- substantive because they did not express an issue APHIS could address . One comment from a non
- governmental organizatio n ( NGO ) had 41,475 signatures appended to it.
Eighty

- five of the comments supported the petition, citing potential improv ed health benefits to consumers and decreased wastage of potato as economically beneficial to the potato industry.
The majority of the negative comments expressed a general dis like of the use of GE organisms. This issue is outside the scope of this EA.

Th e issues that were raised in the public comments which were related to the Simplot InnateTM p otato petition included:

• Contamination of conventional potato production

.
• Concerns that more research should be done prior to approval of the petition.

• Concerns th at plant fitness will be negatively affected.

• Impact that petition approval may have on export markets.

APHIS has analyzed and eval uated the issues described in these comments, and has included a discussion of these issues in this EA with citations where appropriate.
Additionally, on May 30, 2014, APHIS published a notice in the Federal Register (78 FR 31080

- 31082, Docket no. APHIS

- 2012

- 0067) announcing the availability of the Simplot InnateTM potato draft EA (13

- 022

- 01p) and draft PPRA for a 30

- day public review and comment period. Comments were required to be received on or before June 30, 2014.

A total of 60 public comments were received subsequent to the draft EA publication. The majority of those public comments supported the determination of n onregulated status; however, some public comments did not support the determination of nonregulated status. Supporting commenters included individuals from 7 different universities, three trade associations, one industry organization, and 10 farmers.

Of the public comments which opposed nonregulated status for InnateTM potato, the majority of these public comments did not explain or identify elements in the InnateTM potato PPRA or EA that were perceived to be inadequate or provide any supporting evidence for their claims.
Three of the dissenting comments did not contain a letter, but only attached publications and articles. A fourth dissenting comment contained a letter to which 35, 451 signatures of citizens were appended.

8APHIS carefully reviewed the a rticles sent in by commenters. Many of them were included in the EA, many of them pertained to other dockets, but none contributed any new information relevant to Innate TM potato.

1.4 Issues Considered

The list of resource areas considered in this EA was developed by APHIS through experience in considering public concerns and issues identified from public comments submitted for this petition and other EAs of GE organisms. The resource areas address concerns raised in previous and unrelated lawsuits, as w ell as issues that have been raised by various stakeholders for this petition and in the past. The resource areas considered in this EA can be categorized as follows:

Agricultural Production Considerations:

• Land Use of Potato Production

• Agronomic/Cropp ing Practices

• Potato Seed Production

• Organic Potato Production

Environmental Considerations:

• Water Resources

• Soil

• Air Quality

• Climate Change

• Animals

• Plants

• Gene Flow

• Microorganisms

• Biological Diversity

Human Health Considerations:

• Public Health
9• Worker Safety

Livestock Health Considerations:

• Livestock Health/Animal Feed

Socioeconomic Considerations:

• Domestic Economic Environment

• Trade Economic Environment

APHIS evaluated these raised issues and the submitted documentation. APHIS has also included a discussion of these issues in this EA.

102 AFFECTED ENVIRONMENT

This section includes a review of the prevailing conditions of the human environment that may be impacted by Simplot Innate TM p otato production. Relevant environmental components include agricul tural production area of Simplot Innate TM p otato , the physical environment al, biological resources, human health, animal feed, and socioeconomic resources

.
2.1 Agricultural Production and Agronomic Practices of Potato

Potato is the fourth most important crop in the world in terms of human consumption , following rice, wheat , and maize (corn) ( Arvanit oyannis et al. , 2008 ; Llorente et al. , 2011 )

. Potato is grown in over 100 countries , with w orld potato production exceeding 300 million metric tons ( IPC , 2010 )

.
2. 1 .1 Land Use
Potatoes are grown across most of the continental U nited States , with seven States (Colorado, Idaho, Minnesota, North Dakota, Oregon, Washington and Wisconsin) accounting for approximately 77 % of annual production ( USDA

- APHIS, 2013a ) (Figure 1). Within recent years, land devoted to potato production has shifted from the East and Midwes t to the Pacific Northwest. This shift has resulted from a number of factors, including improvements in the U.S. transportation system, the relative decline in consumption of fresh potatoes coupled with advantages associated with processing potatoes in the Northwest such as lower taxes, and lower power and labor costs, more favorable weather , and available land for acreage. The largest potato

- g rowing region by far in the United States is the Snake River Plain of southern Idaho, a major agricultural area where water is available f or irrigation, where nearly all the Idaho crop is grown ( Bechinski e t al. , 2001 ; USDA

- NASS, 2012c ) . The second

- largest growing region is the Columbia Basin in Washington and Oregon, where approximately 137,000 acres were harvested in 2010 ( USDA

- NASS, 2012c ) . Other important areas (wit h 2010 harvested acreage in parentheses) are the Red River Valley, which lies between the northern borders of North Dakota and Minnesota (63,000); San Luis Valley in south central Colorado (55,200), Aroostook County in Maine (50,400), and the Central Sands region of Wisconsin (36,700) ( USDA

- NASS, 2012c )

. Simplot InnateTM p otato events may be grown in any of the U.S. potato

- growing regions.

11

### Figure 1

. Po tato Growing Regions of the United States ( USDA

- NASS, 2007 )

Po tato acres harvested in the United States have ranged between 1.0 and 1.5 million acres since 1951, with highs of 1.5 million in 1953, 1966 and 1967 , and lows of 1.0 million in 2008, 2009 and 2010 ( USDA

NASS, 2012c ) . In most years from 1900 to 1937, more than 3 million acres were harvested, with a high of 3.9 million in 1922 ( USDA

- NASS, 2012c ) . While harvested acreage has declined over the years, total production has increased ( Guenther, 2010a )

. For example, in the 1930s, from about 3.5 million acres of potatoes were harvested, whereas by 1985, production had nearly doub led on less than half the acreage of the 1930s, and by 2005, acreage had declined to about 1 million acres, less than 1/3 the 1930s acreage ( Guenther, 2010a )

. Total annual U.S. production has been over 400 million cwt (one cwt = 100 pounds) every year since 1990, with a peak of 513,544,000 cwt in 2000 ( USDA

- NASS, 2012c ) . Per

- acre yields, which averaged approximately 336 cwt per acre in 2012 , have increased seven

- fold since the early 1900s and have doubled since the early 1960s. For example, in 1901 approximately 2.95 million acres of potatoes were harvested, producing roughly 125 mil lion cwt , or 46.6 cwt per acre ( USDA

- NASS, 2012c ; 2013b )

. The top ten potato producing states shown in Table 1 account for almost 83% of the United Stat es potato crop ( USDA

- NASS, 2013a )

. Highest yields are in regions where daytime temperatures exceed 100° F during the hottest part of growing season, and where nights are cool (about 65° F), such as in Washington’s Columbia Basin, eastern Oregon, California, and Nevada ( Rosen, 2010d )

.
12

### Table 1

. Major Potato Production States

State Production (1,000 cwt ) Percent of Total U.S

. Production

Idaho 141,820 30.6
Washington 95,940 20.7

Wisconsin 29,440 6.4

North Dakota 25,200 5.4

Colorado 23,365 4.8

Minnesota 18,800 4.1
Michigan 15,925 3.4

Maine 15,675 3.4

California 15,501 3.3
Oregon 2,236 0.4

Source: ( USDA

- NASS, 2013a )

Most potatoes are harvested in July through October. Fall crop s have increased because of demand for processing ( Guenther, 2010a )

. Harvested potatoes are either used for food (~93%), feed (< 1%), industrial purposes (<1%) or as “seed” for planting (5%) ( NPC, 2012 ; USDA

- NASS, 2013a ) . Usage is partially dependent on a variety of characteristics related to tuber quality. Only about one quarter of U

. S

. potatoes are consumed fresh ( USDA

- NASS, 2013a ) , while approximately 60% of annual output is processed into frozen products (such as frozen fries and wedges), chips, dehydrated potato and starch (11%) , canned potatoes (0.4%), and 6% is replanted as seed potato. Americans eat, on average, approximately 112 lb s. (51 kg) of potatoes per person per year ( NPC, 2012 )

. Raw potato waste products (peels, out of specification raw potatoes, or other non

- processed raw potato products) and processed disca rds (French fries, hash brown, etc.) are routinely incorporated into feed rations at livestock feedlot operations (Simplot, 2013a)

.
U.S. 2012 potato harvests by state are summarized in Table 2 (in acres).
13

### Table 2

. U.S. 2012 Potato Harvest by State

State Acres Of Potato Harvested

Idaho 344,000
Washington 164,000

North Dakota 84,000

Wisconsin 64,000

Colorado 59,300

Maine 57,000

Minnesota 47,000
Michigan 45,500
Oregon 41,700

California 37,300

Florida 36,600

Nebraska 23,300

Texas 20,100

New York 16,500

North Carolina 16,000

Montana 11,700

Missouri 8,900
Pennsylvania 8,700

Illinois 7,400

Kansas 5,200
Virginia 4,800

Massachusetts 3,900

Arizona 3,700

14Total 1,134,550

Source: ( USDA

- NASS, 2013b )

2. 1 .2 General Agronomic Practices
USDA classifies potato production by season, according to the period when the largest supplies are har vested . Winter, spring and summer potatoes are harvested while the vines are still green and the tubers comparatively immature. These potatoes go directly from the field to fresh markets or into processing.

Fall potatoes are usually harvested when the vines and tubers are mature. M ature potatoes are usually higher in dry matter, which makes them better for most processing , and also have tougher skins, which makes them easier to handle ( Johnson, 2010 ) . A large percentage of the fall crop is stored for processing and fresh market through the winter, spring and summer months. Many modern s torage facilities are equipped with temperature, humidity, and forced

- air ventilation control. Capacity can range from 500 tons to ov er 20,000 tons ( Olsen, 2010 )

. Proper water management is integral to obtaining optimum quality and yield since potatoes are more sensitive to wat er stress than some other crops. Potatoes have a relatively shallow root

- zone depth, and are frequently grown on soils with only fair water

- holding capacities ( King and Stark, No Date )

. The easternmost regions of the United States generally receive enough ra infall in order to produce good quality and yield of potatoes, whereas the western part of the country typically relies on some form of irrigation. Specific guidelines for irrigation depend on geographic region and factors typical of that region such as temperature, relative humidity, and day length. Water requirements also vary to some degree wit h cultivar. Most potato

- growing regions require between 18 and 36 in. of water to produce an optimum crop. Enough moisture to keep plant stomata open during the hottest part of the day is critical ( Shock, 2010 )

. In regions where rainfall is the primary source of water, growers may increase water use efficiency by avoiding steeply sloping fields for planting, and by preparing the so il so that infiltration of water is increased, and by also making ridges in the furrows to mitigate the amount of water running off the field ( Shock, 2010 )

. Timing of water application and amount of water delivered are important to potato production. Some physical defects, such as growth cracks, hollow heart , black spot, and knobby tubers, are directly related to amount and distrib ution of water during the growing season. Excessive water may result in yield reduction and disease s such as Rhizoctonia stem canker , scab, and tuber late blight ( DEFRA, 2006 ; Shock, 2010 ; King and Stark, No Date ) . Too little water at the time of tuber initiation can lead to a reduced number of tubers ( DEFRA, 2006 )

. Daily water needs increase from emergence of plants to

15approximately two wee ks after row closure, but then decline rapidly after onset of vine maturation ( DEFRA, 2006 ; Shock, 20 10 ) . Potatoes need more water during tuber initiation and early tuber development. At harvest, soil water content is also important to reduce mechanical damage to tubers which are frequently associated with dehydration such as black spot bruise, and e xcess water such as shatter bruise and thumbnail cracking ( DEFRA, 2006 ; King and Stark, No Date )

.
P otato Breeding
The tetraploid nature of commercial potato varieties is a significant impedime nt to potato breeding , as well as biological factors su ch as inbreeding depression, and cytoplasmic and nuclear sterility ( Hoopes and Plaisted, 1987 ; Arvanitoyannis et al. , 2008 )

. Due to complex chromosome segregation ratios, polyploid crops are inherently more difficult to breed. Furthermore, veget atively propagated crops like potato are often poor seed producers due to partial or full sterility. For seed propagated crops, like corn or soybean, trait developers often create a single elite event and then backcross that elite event into a wide range of elite germplasm. This is not possible in potato. Each parent variety must be independently transformed to achieve the desired phenotype in that variety ( USDA

- APHIS, 2013a ) . If a sing le variety was transform ed, it c ould take decades to move these new traits into the other commercial varieties by conventional breeding, and even then, it would be difficult to reconstitute the desirable characteristics of the original variety ( Llorente et al. , 2011 ; USDA

- APHIS, 2013a )

. Because maintenance of a vegetatively propagated, disease

- and insect

- free genetic stock is difficult, much of the genetic base is kept as true seed populations ( Spooner, 2010 )

. Cultivation
Potatoes typically require h igh levels of soil cultivation ( Hopkins et al. , 2004 ) , which helps with weed contr ol, aeration, shaping beds, maintaining proper seed depth and establishing irrigation furrows ( Bechinski et al. , 2001 ; Sieczka, 2010 ) . Potato production is generally not conducive to maintaining healthy soil conditions , because of intensive tillage, minimal crop residues left on the field , heavy field traffic and long periods of soil being left bare ( Hopkins, 2010 ) . In the Northwest, potato fields are typically tilled both befor e and after the season ( Hopkins et al. , 2004 )

. In the Red River Valley, between North Dakota and Minnesota, a common practice just before planting is to plow once in the fall, till two or more times during the winter, and disc the field in the spring ( USDA, 2000 )

. Cover Crops
In potato production, a fall cover crop is frequently planted in order to reduce erosion from fields ( Sexton, 2010 )

. Subsequent to mowing the cover crop , the residues may be left on the field to minimize wind erosion ( Rosen, 2010b )

. Another method of reducing erosion as well as mitigated disease pressure is to till green manure crops into the soil prior to planting ( Hopkins et al. , 2004 )

. G rowers in Florida use Sudan grass as a cover crop to provide nitrogen prior to potato pla nting ( Mossler and Hutchinson, 2011 )

. Growing cover crops can also increase yield of the subsequent cash crop ( Cornell University, 2013 )

.

16Crop Rotation
One of the challenges that growers face is the high short

- term economic demand for potatoes to be grown continuously , partly because of the investment that is put into the specialized equipment used in potato growing, and because potatoes represent the highest potential gross return per acre ( Hopkins et al. , 2004 )

. C ontinuous cropping, and short rotations of this crop along with others, causes potato crops to become more susceptible to complications and increases the risk of insect , disease, and nematode pressure, decrease in soil nutrient levels, and a n increase in eros ion potential ( Delahaut, 2000 ; Hall et al. , 2000 ; Bennett and O'Rourke, 2002 ; Larkin, 2003 ; Hopkins et al. , 2004 )

. Lower microbial biomass occurs in fields where continuous cropping is practiced, compared to fields where crops are r otated ( Larkin, 2003 )

. Therefore, frequent rotation of other crops with potatoes is recommended ( Hopkins, 2010 ; Cornell University, 2013 ) in order to increase yield and to reduce insect and disease pressure, as well as to reduce the population density of weeds. Farmers are also advised to avoid planting potatoes near fields where potatoes were planted the previous year. Rotation crops vary with geographical region: for example, in Idaho, potatoes are rotated with small grains, sugar beets, alfalfa, dry beans and

corn ( Hopkins et al. , 2004 ) ; with grains in the Red River Valley in North Dakota and Minnesota ( USDA, 2000 ) ; with malting barley in the San Luis Valley in Colorado ( McDonald et al. , 2003 ) ; and corn, small grains, legumes and green manure crops in Wisconsin ( Delahaut, 2000 )

.
Insect Control
The potato crop is intensively managed with integrated pest management (IPM) to control a variety of insect and disease ( Johnson, 2007 )

. More than 150 species of insects may damage potatoes, most of which cause only minor economic injury . However, several species cause economic injury through feeding on foliage, tub ers, or roots, or by transmitting disease pathogens to the plant. While major insect pests vary within production regions, the most serious overall is th e Colorado potato beetle. In the eastern U.S., leafhoppers can also cause yield loss to plants before plants present any visual symptoms of feeding damage; several leafhopper species are serious problems because they vector phytoplasmas ( Radcliffe, 2010 ) . Aphid

- transmitted diseases cause greater economic losses than all other insect damage combined together. At least 9 pota to viruses are transmitted via aphids , the most important of which is potato leaf roll virus (PLRV), vectored primarily by green peach aphid, and potato Y virus (PVY), vectored by potato aphid, pea aphid, melon aphid, buckthorn

- potato aphid, soybean aphid, and bird cherry

- oat aphid ( Radcliffe, 2010 ; Rondon, 2012 )

. Occasional pests include armyworm, loopers, cutworms , and spider mites ( Rondon, 2012 )

. Some soil insects can cause a decrease in quality of tubers, but generally cause little decrease in yield. The m ost important of these are wireworms, the larval stage of elaterid beetles ( Bechinski et al. , 2001 ) , particularly if fields are laden with sod sometime before planting ( Roberts and Cartwright, No Date )

. Growers may also mitigate insect pressure by avoiding planting on fields nearby cornfields since European corn borer may also infest potato ( Cornell University, 2013 )

. Insec t pests in stored corn

17include potato tuber moth, Phthorimaea operculella, and seed corn maggot, Delia platura ( Rondon, 2012 )

.



### Table 3

. Major Insect Pests of Potato

Common Name Scientific Name
Colorado potato beetle Leptinotarsa decemlineata
Green peach aphid Myzus persicae

Wireworms Limonius californicus, L. canu, Ctenicera pruinera
Potato leafhopper Emposasca fabae
Pea aphid Acyrthosiphon pisum
Soybean aphid Aphis glycine
Thrips Franklinella spp., Thrips spp.

Flea beetle Epitrix spp.
European cornborer Ostrinia nubilalis
Potato psyllid Bactericera (Paratrioza) cockerelli

Potato Tuber worm or Tuber Moth Phthorimaea operculella

Sources: ( Radcliffe, 2010 ; Rondon, 2012 ; Roberts and Cartwright, No Date )

Disease Control

Potato d iseases can be caused by viruses, viroids, phytoplasmas, and most importantly, by bacteria and fungi

. Infection can occur when cutting potatoes into seed pieces prior to planting , in which a disease organism present in the seed potato is transmitted to the resulting potato plant. The cut surfaces of the seed pieces, until they are suberized, are open wounds that provide a route of entry for pathogens ( Davidson, 2010 )

.

18Potatoes can become infected with a number of viruses (e.g. potato leafroll virus, and potato viruses A, M , X and Y); however, IPM options for virus pests are limited to insecticidal control of their insect vectors and planting of resistant varieties, including some GE varieties ( Arif et al. , 2012 ; USDA

- APHIS, 2013a )

. There are several factors to consider in controlling potato diseases, including part of the plant being attacked, pathogen transmission mechanism, and environmental conditions

. Table 4 lists the major diseases of potato. Some of these are more common while plants are in the field, while others only emerge during storage ( Bechinski et al. , 2001 )

. Growers may plant disease

- resistant cultivars, use certified seed, spray fungicides, and rotate potato with other crops in order to mitigate disease pressure ( Johnson et al. , 2010 ; Hollingsworth, No Date )

.



### Table 4

. Major D iseases of Potato

Common Name Scientific Name

Bacteria

Aster Yellows MLO Member of Acholeplasmataceae
Bacterial ringrot Corynebactium sepedonicum

Bacterial brown rot Ralstonia solanacearum

Bacterial soft rot Pectobacterium carotovorum
Blackleg Erwinia carotovora

Golden nematodes Globodera rostochiensis

Potato tuber rot Ditylenchus destructor

Root knot Meloidogyne spp.

Columbia root knot Meloidogyne chitwoodi

Root lesion Pratylenchus penetrans

Viruses

Potato Leafroll Virus Luteovirus

19Common Name Scientific Name

Potato Spindle Tuber Viroid Member of Pospiviridae

Potato Virus A,M, X, Y Members of Potyviridae, Carlavirus,

Tobacco Rattle Virus Tobravirus
Fungi

Late blight Phytophora infestans

Pink rot Phytophthora erythroseptica
Early dying Verticillium spp.

Sclerotinia stalk rot or white mold Sclerotinia sclerotiorum

Canker or black scurf Rhizoctonia solani

Scab Streptomyces scabies

Dry rot Fusarium spp.

Fusarium wilt Fusarium solani var eumartii, Fusarium oxysporum

Water or shell rot Pythium ultimum
Early blight Alternaria solani
Gray mold Botrytis cinerea

Black dot Colletotrichum coccodes

Ring rot Clavibacter michiganensis subsp. Sepedonicus
Powdery scab Spongospora subterranea

Silver scurf Helminthosporium solani

Wart Synchytrium endobioticum

Nematodes

Golden nematodes Globodera rostochiensis

Potato tuber rot Ditylenchus destructor

20Common Name Scientific Name

Root knot Meloidogyne spp.

Columbia root knot Meloidogyne chitwoodi

Root lesion Pratylenchus penetrans

Sources: ( Johnson et al. , 2010 ; Roberts and Cartwright, No Date )

Weed Management
Weeds pose a management issue for growers, potentially causing a significant loss in yield by outcompeting potatoes for nutrients, water and sunlight. Tillage and herbici de usage can help control weeds ( Delahaut, 2000 ; Hutchinson, 2010 ) , although tillage can also damage potato plants and reduce yields. Common weeds in potato fields fall into three main classes: annual broadleaf plants , which are the easiest to control, with the exception of nightshade; annual grasses, which may germinate later than most broadleaf annuals; and perennials, which are the most difficult to control ( Hutchinson, 2010 ; Cornell University, 2013 )

. Major weed species in potato fields are noted in Table 5 . In addition to competition with potato plants for resources, weeds are detrimental to the crop due to potential penetration of potato tubers by weed roots, causing a severe reduction in crop quality ( Hutchinson, 2010 )

.



### Table 5

. Major Weeds of Potato

Broadleaf Annuals Annual Grasses Perennials
Hairy nightshade ( Solanum sarrachoides )
Common lambsquarters ( Chenopodium album )
Redroot pigweed ( Amaranthus retroflexus )
Ragweed ( Ambrosia artemisiifolia )
Kochia ( Kochia scoparia ) Barnyardgrass ( Echinochloa crus

galli )
Foxtail ( Setaria spp.)

Wil d oat ( Avena fatua )
Fall panicum ( Panicum dichotomiflorum ) Nutsedges ( Cyperus spp.)
Quackgrass ( Elytrigia repens )
Canada thistle ( Cirsium arvense )

21Pennsylvania smartweed ( Polygonum pennsylvanicum )

Source: ( Hutchinson, 2010 )

In order to mitigate weed problems, g rowers should avoid planting potatoes on fields with heavy infestations of weeds. Most growers also scout their fields to assess the need for herbicides, and choose rotational crops that compete successfully with weeds ( Bechinski et al. , 2001 )

. Commonly used herbicides are metribuzin, EPTC, and metolochlor ( USDA, 2000 ; Bechinski et al. , 2001 ; McD onald et al. , 2003 ) . Growers may also rotate herbicide use according to chemical class in o rder to avoid or delay the development of weed resistance ( Bechinski et al. , 2001 )

. Volunteer Potatoes
Volunteer potatoes are tubers that are left in fields after a harvest , which compete with rotational crops for sunlight, water, and essential nutrients , and then compete with a subsequent potato crop

. In addition to becoming weeds, v olunteer potatoes can a lso be hosts for disease such as late blight, potato leaf roll, and virus Y ( Eberlein et al. , 1998 ; Boydston and Williams, 2005 ) . Several herbicides can be used for the control of volu nteer potato plants ( ( Boydston and Williams, 2005 ; Everman and Long, 2010 )

. Other control measures may include p ost

- harve st grazing and rotation to crops competitive with the volunteers ( Eberlein et al. , 1998 )

. In general, potato is a poor colonizer in wild ecosystems. Outside agricultural fields, volunteer potato seedlings cannot compete well with other plants, and, therefore, are unlikely to establi sh themselves. During transportation and processing, there is a possibility of tubers being released, but again, there is little probability of successful establishment ( OECD, 1997 )

. Organic Potatoes To bear a certified organic label, farms grossing more than $5,000/year in revenues must be c ertified by a USDA National Organic Program (NOP) accredited certifying agency. Certifying agencies also have specific cultural requirements with regard to field selection (e.g., fields cannot have been treated with prohibited chemicals for 3 years before harvest of a certified organic crop, and there must be sufficient buffer zones between certified organic crops and conventionally grown crops in order to reduce potential contamination between the two such as via pollination) ( Cornell University, 2013 )

. There are other requirements and recommended practices for organic potato production see, e.g., ( Moore and Olsen, No Date ) for organic po tato production in Idaho, and ( Hollingsworth, No Date ) for or ganic potato production in California.

In terms of US organic potato production, measured in cwt /year , the leading states are Washington (>600,000) , Colorado (>500,000) , California (>400,000) , Oregon (>300,000) , Idaho (>200,000) , and much

22lesser amounts fr om Maine (>25,000) , Wisconsin (>23,000) , Ohio (>17,000), and Vermont (>7,000) ( USDA

- NASS, 2008 )

. In terms of sale s/year, the l eading states are California (>$10 million), Colorado (>$6 million), Washington (>$4 million), Oregon (>$3 million), and Idaho and Maine (each state, >$1 million) ( USDA

- NASS, 2008 )

. As discussed in Section 2.3.1, Domestic Economic Environment, organic potatoes command a premium price compared to conventionally grown potatoes.

Potato Seed Production

Potatoes are vegetatively propagated by planting tubers or seed pieces ( Davidson, 2010 ; NSF, 2011 ) . In 2012, approximately 6 percent of the 2012 ann ual potato crop wa s used as seed ( NPC, 2012 ) in the form of seed potatoes. Certified seed potatoes are produced to ensure genetic purity and to reduce disease introduction ( NPC, 2012 ) . Most seed that is sold is labeled certified seed ( USDA, 2000 ) , which means that certification agency requirements must be met

. These requirements include inspections of fields, storage facilities, and shipping points in order to evaluate whether dis ease incidence exceeds established thresholds ( Moore and Olsen, No Date )

. There are 16 potato seed certi fication agencies in the United States , including one in each major production state ( NPC, 2012 )

. Typically, s eed potatoes are grown in the same areas where potatoes for commercial production are grown, although the areas of maximum seed production so metimes differ from the areas of maximum tuber production . Majo r seed production states in 2012 in order of de creasing production were Idaho (>35,000 acres harvested), North Dakota, Colorado, Maine , Wisconsin and Minnesota (>7,000 acres harvested) ( USDA

- NASS, 2013a )

. The use of good quality seed potatoes is important to successful potato culture. It is recommended that seed size be ideally about two to four ounces, about the size of a golf ball ( Hollingsworth, No Date )

. Potato Processing and Storage
About 60% of potatoes are processed into frozen commodities such as French fries and shoestring potatoes and dehydrated. Typically, frozen and dehydration industries are concentrated in the Northeast, upper Midwest, and Pacific Northwest. Potato chip processers tend to be more evenly distributed throughout the count r y because chips are fragile , and long

- distance shipping is expensive. Therefore, chipping plants tend to be located near heavily populated area s ( Guenther, 2010b )

. Long

- term s torage is needed for processing operations. Capacities of storage facilities typically range from 500 to >20,000 tons. Most of the tubers are kept in bulk piles, but some facilities use box storage. In northern production areas, a large percentage of th e potato crop is stored for processing and fresh market uses during the winter, spring, and summer months. Storage facilities are frequently equipped with ventilation systems and systems to monitor temperature, relative humidity and carbon dioxide levels. Some storage facilities are refrigerated to cool stored potatoes during w armer spring and summer months ( Olsen, 2010 )

. Potatoes kept stored for > 130 days h ave a tendency to sprout, and are therefore chemically treated to prevent sprout formation ( Kleinkopf, 2010 ) . Prolonged storage can also

23lead to lowered tuber quality from moisture loss , which can cause tuber surface wrinkling ( Arvanitoyannis et al. , 2008 )

.
2.2 Physical Environment

2. 2 .1 Water Resources
The principal law governing pollution of the nation’s water resources is the Federal Water Pollution Control Act of 1972, better known as the Clean Water Act (CWA). The Act utilizes water quality standards, permitting r equirements, and monitoring to protect water quality. The EPA sets the standards for water pollution abatement for all waters of the United States under the programs contained in the CWA, but, in most cases, gives qualified states the authority to issue a nd enforce permits. Drinking water is protected under the Safe Drinking Water Act of 1974 (Public Law 93

- 523, 42 U.S.C. 300 et seq .).
Surface water in rivers, streams, creeks, lakes, and reservoirs supports everyday life through the provision of water f or drinking and other public uses, irrigation, and industry. Surface runoff from rain, snowmelt, or irrigation water can affect surface water quality by depositing sediment, minerals, or contaminants into surface water bodies. Surface runoff is influence d by meteorological factors such as rainfall intensity and duration, and physical factors such as vegetation, soil type, and topography. Agricultural production, including potatoes, can adversely impact surface water quality, primarily through sedimentati on from erosion and nutrient loading from fertilizers ( US

- EPA, 2005 ; 2009a )

. Nitrogen loss in the form of ammonium and nitrates to surface water can occur as a result of direct runoff, or by infiltration through the root zone, and discharge to surface water by drainage or seepage ( Zebarth et al. , 1999 )

. Groundwater is the water that flows underground and is stored in natural geologic formations called aquifers. It sustains ecosystems by releasing a constant supply of water into wetlands and contributes a sizeable amount of flow to permanent streams and rivers. Based on 2005 data, the larges t use of groundwater in the United States is irrigation, representing approximately 67.2% of all the groundwate r pumped each day ( McCray, 2009 ) . In the United States , approximately 47% of the population depends on groundwater for its drinking wate r supply. The EPA defines a sole source aquifer (SSA) as an aquifer that supplies at least 50% of the drinking water consumed in the area overlying the aquifer. An SSA designation is one tool to protect drinking water supplies in areas where there are fe w or no alternative sources to the groundwater resource. There ar e 77 designated SSAs in the United States and its territories ( US

- EPA, 2011e )

. Crop production has the potential to impact groundwater in areas with shallow (less than approximately 15 feet deep) water tables through leaching of the nitrates from fertilizers fertilizers ( Nolan et al. , 2002 ; DEFRA, 2006 )

. Agricultural production leads to nitrate contamin ation of groundwater through leaching associated with high applications of manure or fertilizers or excessive irrigation ( Zebarth et al. , 1999 ; DEFRA, 2006 )

.

24Unlike a point source which is a “discernible, confined and discrete conveyance”, nonpoint source (NPS) pollution comes from m any diffuse sources. Rainfall or snowmelt moving over the ground, also known as runoff, picks up and carries away natural and human

- made pollutants, creating NPS. The pollutants may eventually be transported by runoff into lakes, rivers, wetlands, coasta l waters and ground waters. Agricultural NPS pollution includes animal wastes, fertilizers, and pesticides. Surface water may be contaminated by agricultural sediments transported by erosion that may also include pesticides, fertilizers, and sometimes fu el and pathogens. Agricultural practices that introduce contaminants into the groundwater include fertilizer and pesticide application, spilled oil and gasoline from farm equipment, nitrates, and pathogens from animal manure.

NPS pollution is the leading source of water quality impacts on rivers and lakes, the second largest source of impairments to wetlands, and a major contributor to groundwater contamination ( US

- EPA, 2005 ) . Management practices that contribute to NPS pollution include the type of crop cultivated, plowing and tillage, and the application of pesticides, herbicides, and fertilizers. The primary cause of NPS pollution is increased sedimentation in surface waters following soil erosio n ( US

- EPA, 2005 )

. The major contribution to groundwater contamination derives from agricultural areas (nitrogen inputs from fertilizer and manure drainage and leaching from root

- zone areas due to over
- irrigation; and sal ts in the form of carbonates, sulfates, and chlorides, from drainage ) and is influenced by regional environmental factors such as precipitation and soil characteristics ( Skaggs et al. , 1993 ; US

- EPA, 2003 ; King and Stark, No Date )

. Nutrients applied in excess of recommended application rates are listed as the second cause of impairment in lakes, reservoirs, and ponds, with agriculture listed as the third most probable source of the impairment ( US

- EPA, 2012b )

. Agricultural pollutants released by soil erosion include sediments, fertilizers, and pesticides that are introduced to area lakes and streams when they are carried off of fields by rain or irrigation waters ( US

EPA, 2005 ) . Increase in sediment loads to surface waters can directly affect fish, aquatic invertebrates, and other wildlife maintenance and survival. It also reduces the amount of light penetration in wat er which directly affects aquatic plants. Indirectly, soil erosion

- mediated sedimentation can increase fertilizer runoff, thereby increasing nutrient loading and facilitating higher water turbidity, algal blooms, and oxygen depletion ( Skaggs et al. , 1993 ; US

- EPA, 2005 )

. O ver
- fertilization should be avoided to prevent nutrient leaching into groundwater, risk of ground water pollution with nitrates , and risk of estuary pollution from nitrates and phosphates ( Carroll and Robinson, 2006 ) . Preservation and conservation of water and soil resources must be maximized and non

- point

- source pollution must b e minimized ( Carroll and Robinson, 2006 )

. Most of t he potatoes produced in the United States ar e grown under irrigation , including potatoes grown in Idaho, Washington, Oregon, California, and Wisconsin, whereas r ainfall provides adequate moisture for potato crops in the eastern United States ( Shock, 2010 ; King and Stark, No Date )

. Potato yield can be reduced by both under

- and over

- irrigating ( King and Stark, No Date )

. Potato processing can contribute to eutrophication of water ( DEFRA, 2006 )

.

252. 2 .2 Soil Quality
Soil consists of solids (minerals and organic matter), liquid s, and gases. This body of inorganic and organic matter is home to a wide variety of fungi, bacteria, and arthropods, as well as the growth medium for terrestrial plant life ( USDA

- NRCS, 2004 ) . Soil is characterized by its layers that can be distinguished from the initial parent material due to additions, losses, transfers, and transformations of energy and matter ( USDA

- NRCS, 1999 ) . It is further distinguished by its ability to support rooted plants in a natural environment. Soil plays a key role in determining the capacity of a site for biomass vigor and production in terms of physical support, ai r, water, temperature moderation, protection from toxins, and nutrient availability. Soils also determine a site’s susceptibility to erosion by wind and water, and flood attenuation capacity.
Soil properties change over time; temperature, pH, soluble salt s, amount of organic matter, the carbon

nitrogen ratio, numbers of microorganisms and soil fauna all vary seasonally, as well as over extended periods of time ( USDA

- NRCS, 1999 ) . Soil texture and organic matter levels directly influence its shear strength, nutrient holding capacity, and permeability. Soil taxonomy was established to classify soils according to the relationship between soils and the factors responsible for their character ( USDA

- NRCS, 1999 ) . Soils are organized into four levels of classification, the highest being the soil order. Soils are differentiated based on characteristics such as particle size, texture, and color, and classified taxonomically into soil orders based on observable properties such as organic matter content and degree of soil profile development ( USDA

- NRCS, 2010 ) . The Natural Resources Conservation Service (NRCS) maintains soil maps on a county level for the entire United States and its territories.
There are a multitude of organisms associated with soils, ranging f rom microorganisms to larger organisms, such as worms and insects. The microbial populations of the soil encompass an enormous diversity of bacteria, algae, fungi, protozoa, viruses, and actinomycetes (filamentous bacteria) ( Doran et al. , 1996 ) .The extent of the diversity of microorganisms in soil is seen to be critical to the maintenance of soil health and quality. Microorganisms in soil are critical to the maintenance of soil function in both natural and managed agricult ural soils because of their involvement in such key processes as soil structure formation; decomposition of organic matter; toxin removal; and the cycling of carbon, nitrogen, phosphorus, and sulfur ( Bruinsma et al. , 2003 )

. In addition, certain microbial organisms may contribute to the protection of the root system against soil pathogens ( Garbeva et al. , 2004 )

. Potatoes grow well in a wide range of soils. Optimum soils are deep, loose, and drain well ( Rosen, 2010c )

. Poorly drained soils tend to yield poorly shaped tubers and tubers which are susceptible to diseases like tuber rot ( Plissey and Erhardt, 2000 ; Johnson and Sideman, 2006 )

. Sandy soils can also produce high

- quality potatoes, but these soils are more susceptible to wind erosion ( Rosen, 2010b )

. The ability of soils to retain water is important because the drier soil becomes, the more difficult it is for the crop to pull water from it, and is dependent on soil texture and structure ( DEFRA, 2006 )

. M aintaining organic matter in soil is advisable because it keeps the soil loose and well

- aerated, which in turn, leads to better penetration of root structures, and development of tubers , but is a problem in almost all regions where potatoes are grown except for those areas where soils contain muck and peat ( Rosen,
262010a )

. The recommended pH for soils is slightly acidic, which helps reduce incidence of diseases such as scab ( Plissey and Erhardt, 2000 ; Johnson and Sideman, 2006 )

.
Mai ntaining adequate soil conditions in potato fields may be difficult due to crop tillage, low crop residues on soil surfaces, and foot traffic from agricultural workers , which can lead to higher erosion rates . Erosion mitigation strategies include growing a cover crop and utilizing the subsequent crop plant residues ( Hopkins et al. , 2004 )

. Where potatoes are grown in fields with stones such as in Maine , removal of stones may ease movement of mechanical harvesters, but may also negatively affect tuber yield ( Saini and Grant, 1980 ) . Soil compaction can occur with excessive tillage ( Roberts and Cartwright, No Date ) , continuous cropping, and the use of large agricultural machines and increased pesticide spraying operations. As the number of machinery passes through the fields increases, soil compaction incre ases, and oxygen diffusion rate to roots decreases, which in turn may lead to a reduction in tuber size and increased soil erosion ( Saini and Grant, 1980 ) . Compacted soil also reduces the ability of roots to find water in soil ( DEFRA, 2006 )

.
2. 2 .3 Air Quality

The Clean Air Act (CAA) requires the maintenance of National Ambient Air Quality Standards (NAAQS). The NAAQS, developed by the EPA to protect public health, establish limits for six criteria pollutants: ozone (O 3 ), nitrogen dioxide (NO 2 ), carbon monoxide (CO), sulfur diox ide (SO 2 ), lead (Pb), and inhalable particulates (coarse particulate matter [PM] greater than 2.5 micrometers and less than 10 micrometers in diameter [PM 10 ] and fine particles less than 2.5 micrometers in diameter [PM 2.5 ]). The CAA requires states to ach ieve and maintain the NAAQS within their jurisdiction. Each state may adopt requirements stricter than those of the national standard and each is also required by EPA to prepare a State Implementation Plan (SIP) containing strategies to achieve and mainta in the national standard of air quality within the state. Areas that violate air quality standards are designated as non

- attainment areas for the criteria pollutant(s), whereas areas that comply with air quality standards are designated as attainment area s. Non

- attainment areas are typically associated with large metropolitan areas with many mobile (e.g., vehicle) and stationary (e.g., power plants and factories) sources. Other than emissions from mobile sources, crop farming emission sources are not spec ifically regulated nationwide under the CAA. The degree to which emissions from farming practices (such as prescribed burning) are allowed are location

- specific within each State Implementation Plan ( US

- EPA, 2011e ) . Regulation of agricultural sources within a State Implementation Plan does not appear to be typ ical. For example, based on a review of the available plans in Idaho, achievement of air quality standards is focused on managing residential wood burning, vehicle emissions, and facilities such as factories and processing plants ( US

- EPA, 2011b )

. Agricultural production may produce air emissions such as fugitive dust from the disturbanc e of bare soil from farming activities or wind, vehicle emissions, and emissions associated with fertilizer and pesticide applications . In some agricultural areas, prescribed burning is practiced and results in higher air emission s levels ( US

- EPA, 2011a )

. Ammonia may be lost to the atmosphere via inorganic nitrogenous fertilizers, but occurs mostly from livestock production processes such as ma nure storage and 27application. Atmospheric ammonia can then contribute to the eutrophication of surface water and acidification of soil and water ( Zebarth et al. , 1999 )
The US EPA regulates mobile source emissions by reformulated gasoline and automobile pollution control devices ( US

- EPA, 2011a ) . Stricter requirements, such as vapor recovery nozzles on gas pumps, may apply in non

- attainment areas.

2. 2 .4 Climate Change
Climate change represents a statistical change in global climate conditions, including shifts in the frequency of extreme weather. Agriculture is recognized as a direct (e.g., exhaust from equipment) and indirect (e.g., agricultural

- related soil disturbance) source of greenhouse gas (GHG) emissions. The EPA has identified carbon dioxide (CO 2 ), methane (CH 4 ), and nitrous oxide (N 2 O) as the most important GHGs contributing to climate change. While each of these gases occurs naturally in the atmosphere, human activity has significantly increased the concentration of these gases since the beginning of the industrial revolution. The level of human produced gases accelerated even more so after the end of the Second World War, when industrial and consumer consumption expanded greatly. Wit h the advent of the industrial age, there has been a 36% increase in the concentration of CO 2 , 148 % in CH 4 , and 18 % in N 2 O ( US

- EPA, 2012a )

Gree nhouse gases vary in their global warming potential (GWP), and the US EPA converts all gases to carbon dioxide (CO 2 ) equivalents. For the three greenhouse gases most associated with agriculture, GWPs are as follows: CO 2 = 1, methane (CH 4 ) = 21, and nitrous oxide (N 2 O) = 310 ( US

- EPA, 2012a ) . The US EPA classifies different sources by sector, with the energy sector be ing the largest contributor of greenhouse gas emiss ions ( US

- EPA, 2012a ) . The agriculture sector, as defined by US EPA, represente d 6.3 % of total green house gas emissions for the United States in 20 10 ( US

- EPA, 2012a ) . However, this does not include CO 2 em issions and removals from agricultural

- related land use activities such as liming of agricultural soils (which are included in the land use sector) and it does not include emissions of CO 2 and N 2 O from diesel or gasoline

- powered agricultural equipment (whi ch are included in the energy sector). The primary greenhouse gases contributed by the agriculture sector as defined by US EPA are N 2 O and CH 4 . The relative percent contribution to total CO 2 equivalent emissions of the various agricultural sources in 201 0 was as follows: agricultural soil management (fertilizer application and other cropping practices that contribute N 2 O), 49 percent; enteric fermentation (primarily methane emissions from cattle), 33 percent; manure management, 16 percent; and rice culti vation, two percent. Most of the climate change potential from potato production is derived from transportation, packing and processing of potatoes. Emissions from field burning of agricultural residues, the remaining category, were less than 0.1 p ercent of the total ( DEFRA, 2006 ; US

- EPA, 2012a )

.

282.3 Biological Resources
This section provides a summary of the biological environment and includes an overview of animals, plants, microorganisms, and biodiversity associated with potato production . This summary provides the foundation to assess the potential impact to plant and animal communities

.
2. 3 .1 Animal Communities
Animal communities in this discussion include wildlife species and their habitats. Wildlife refers to both native and introduced species of mammals, birds, amphibians, reptiles, invertebrates, and fish or shell fish. Agriculture dominates human uses of land ( Robertson and Swinton, 2005 ) . In 2011, 917 million acres (approxi mately 47%) of the contiguous 48 states wer e devoted to farming, including crop production, pasture, rangeland, and Conservation Reserve Program areas ( USDA

- NASS, 2012b ) . How these lands are maintained influences the function and integrity of ecosystems and the wildlife populations that they support.
A wide array of wildlife species oc cur within the major potato

- producing U.S. states and could possibly be found in potato fields at least intermittently. There are reports of wildlife feeding on foliage of potato, but reports of damage resulting in economic loss are uncommon. This is not surprising considering that the foliage and stems of potato contain toxic glycoalkaloids known to cause illness when consumed ( Sinden, 1987 ) . In 1992 , APHIS Wildlife Services conducted formal appraisals of wildlife damage on 490 acres of potatoes in Wisconsin and did not report any damage or economic loss ( USDA

APHIS, 2013c ) . However, white tailed deer have been reported to damage pota toes in some areas ( Marinette County, 2014 ) and it is well known that wild boar and voles will feed on tubers ( O'Brien, 2005 ; Taylor, 2014 ) . USDA

- APHIS Wildlife Services has also received complaints for damage caused by sandhill cranes ( US DA

- APHIS, 2013c )

. There are numerous insects found in and around potato fields. Some insects and other invertebrates can be beneficial to potato production, providing services such as nutrient cycling and preying on plant pests. M any insects and invertebrates are detrimental to potato crops, including: Colorado potato beetle ( Leptinotarsa decemlineata ), various aphid species including the green peach aphid ( Myzus persicae ), wireworms ( Limonius californicus, L. canus, Ctenicera pruinina ), flea bee tles ( Epitrix sp

. ), European corn borer ( Ostrinia nubilalis), potato psyllid ( Bactericera (Paratrioza) cockerelli ), tuberworm ( Phthorimaea operculella ), and the potato leafhopper ( Emposasca fabae ) ( Johnson, 2007 ; Simplot, 2013b ) . Nematodes can also be found in potatoes such as the root knot nematodes ( Meloidogyne spp. ), and cyst nematodes ( Globodera pallida ) and ( G. rostochiensis ) ( Hardy, 1996 )

. The potato crop is intensively managed with integrated pest management (IPM) practices to control these insects, nematodes, and several disease pathog ens that include fungi, bacteria and viruses ( Johnson, 2007 ) and to e nhance potato yield. As a result, pesticides, including insecticides, nematicides, and fungicides , are generally part of an IPM strategy to keep losses below economic threshholds ( US

- EPA, 2000 ; Senseman, 2007 ) . Conventional broad

- spectrum insecticides are potentially toxic to invertebrates and vertebrates. The US

- EPA requires application control measures for certain Rest ricted Use insecticides to limit human
29and environmental exposure. These impacts can affect animal communities, with those communities within and in close proximity to potato fields experiencing the greatest impact ( US

- EPA, 2000 ; 2009b )

.
2. 3 .2 Plant Communities
The landscape surrounding a potato field may be bordered by other potato fie lds, other crops, or may be surrounded by forest, grassland, bodies of water, or built

- up areas. As discussed in Section 2. 1 , most commercial potatoes are grown in large agricultural areas, such as the Snake River Valley in Idaho. Thus, other crops would most frequently make up the surrounding vegetation, although some fields would be bordered by non

- crop vegetation. Growers may provide buffer zones to reduce or prevent impact to adjacent vegetation. Because potatoes are g rown throughout much of the United States , a wide variety of plants may be found adjacent to the agricultural fields. These plants have the potential to be impacted by agricultural practices, including the use of pesticides, which are regulated by US EPA. Aquatic plant communities near agricultural fields may be affected by sedimentation resulting from erosion, or by nutrients leached from fertilizers.
Plants which compete with potato in crop fields are generally regarded as weeds, an d are discussed in Section 2. 1 .2, General Agron omic Practices

. Native or wild plant species related to cultivated potatoes are of interest because of the potential for interbreeding through gene flow. By definition, interbreeding between species that result in viable offspring is not common; otherwise the two plants would not be classified as different species. Interbreeding can occur to a limited extent between some species under some circumstances. Among the many factors that must be present for hybridization to occ ur between two species are : 1) the species must occur in the same area and habitat, 2) the flowering periods of the species involved must overlap, and 3) appropriate pollinat ors must be present ( OECD, 1997 )

. Section 2. 3 .3, Gene Flow and Weediness discusses this subject.
Threatened and Endangered Species
There are currently thre e plants in the genus Solanum on the U.S. Fish and Wildlife Service (US FWS) list of threatened or endangered plant species: Erubia ( S. drymophilum ), found only in Puerto Rico; and popolo ku mai ( S. incompletum ) and Aiakeakua popolo ( S. sandwicense ), both found only in Hawaii ( FWS, 2011 ) p. 47). B ased on the evaluation of wild potatoes presented above, these species would not interbreed with cultivated potatoes; additionally, potatoes are not commercially grown in these areas.

2. 3 .3 Gene Flow and Weediness
Gene flow is a biological process that fa cilitates the production of hybrid plants, introgression of novel alleles (i.e., versions of a gene) into a population, and evolution of new plant genotypes. Gene flow to and from an agro

- ecosystem can occur on both spatial and temporal scales. In genera l, plant pollen tends to represent the major reproductive method for transmission across geographic areas, while both seed and vegetative propagation tend to promote the movement of genes temporally and spat ial l y

.

30The rate and success of gene flow is depen dent on numerous external factors in addition to the donor/recipient plant. General external factors related to pollen

- mediated gene flow include the presence/abundance/distance of sexually

- compatible plant species; overlap of flowering phenology between populations; the method of pollination; the biology and amount of pollen produced; weather conditions, including temperature, wind, and humidity ( Zapiola et al. , 2008 ) . Seed

- mediated gene flow also depends on many factors, including the ab sence/presence/magnitude of seed dormancy; contribution and participatio n in various dispersal pathways, envir onmental conditions , and events.
Volunteer potatoes arise from overwin tered tubers, and can be a weed problem in the following crop. Potatoes have a fairly low frost tolerance, and tubers planted too shallowly are subj ect to loss by frost. I n temperate climates up to 20 % of tubers left in the soil show no dormancy and wil l sprout the next

season ( Andersson and de Vicente, 2010 ) . However, volunteer potatoes can be easily controlled with cultivation and herbicides and do not persist as weeds for more than one or a few years ( Andersson and de Vicente, 2010 ) . In general, potato has a low propensity for weediness or persistence and is incapable of survival outside of agricultural production ( Holm et al. , 1979 ; Muenscher, 1980 ; Love, 1994 ; OECD, 1997 )

. Gene flow by hybridization is not possible for some potato cu ltivars such as the Russet Burbank, the most commonly grown potato, because they are reproductively sterile ( PAA, 2009a ; NSF, 2011 ; Simplot, 2013b )

. Pollination of potato is mostly by bumblebees ( Bombus impatiens ), whi ch have a relatively short flight range (less than three kilometers ) ( OECD, 1997 ) . P ollen dispersal by nectar

- seeking pollinators is limited b ecause potato flowers are without any nectar. T he honeybee ( Apis mellifera ) and Bombus fervidus are not attracted to them, and wind plays an insignificant role in pollination ( OECD, 1997 ) . Empirical field testing of outcrossing distances in potato show that separations of 20 meters or more are sufficient to prevent outcrossing ( Conner and Dale, 1996 )

. Based on the relative lack of pollinator importance in potato production, APHIS does not further consider pollinator issues in this assessment.

Of the fertile varieties , which include Ranger Russet, Atlant ic and “G” , about 80 to 100 percent of true seed produced is derived from self

- pollination ( Hoopes and Plaisted, 1987 )

. A potential source of volunteers is true potato seed (TPS). TPS is seed produced via pollination, which develops inside small fruiting bodies formed on the potato vine. Its major disadvantage is that it segregates for numerous traits because potato is highly heteroz ygous, and plants arising from TPS typically take longer to establish and set tubers, resulting in lower yield than from seed potatoes ( Pallais, 1987 ; Simplot, 2013b )

. Of the five parent varieties used to develop the 10 Simplot InnateTM p otato events, Russet Burbank and “H” are fully sterile, precluding any possibility of TPS production. However, the Simplot InnateTM p otato events derived from Ranger Russet, Atlantic and “G” are fertile and may produce TPS. But plants produced from TPS are no weedier than volunteer plants produced from over

- wintered tubers and are relatively easy to control in rotational crops

. Potato ( Solanum tuberosum) belongs to the Solanaceae plant f amily, along with other cultivated crop plants such as tomato ( Solanum lycopersicon ), eggplant ( Solanum melogena ), tobacco ( Nicotiana
31tabacum ) , and pepper ( Capsicum annuum ) ( OECD, 1997 )

. S. tuberosum is divided into two subspecies: tuberosum and andigena . The subspecies Solanum andigena is also a cultivated species, but its cultivation is restricted to Central and South America ( OECD, 1997 )

. While there appears to be minimal, if any, overlap geographically between cultivat ed and wild potatoes in the United States , there is a possibility that a few wild potato plants may be g rowing near potato fields ( Love, 1994 )

. However, t he potential for hybridization between wild and domesticated potatoes is extremely unlikely. Approximately 200 species of wild potatoes have been identified ( Hijmans and Spooner, 2001 ) , but only two species grow within U

. S

. borders, the tetraploid species Solanum fendleri (recently reclassified as Solanum stoloniferum ) and the diploid species Solanum jamesii ( Bamberg et al. , 2003 ; Bamberg and del Rio, 201 1 ) . In addition to geographic separation ( US

- EPA, 2011c ) , there are several biological barriers to gene transfer such as multiple ploidy levels and endosperm imbalances ( Love, 1994 )

. Hybridization between native and cultivated potatoes has never be en reporte d in the United States , although gene transfer has been accomplished using special laboratory techniques ( Love, 1994 ; US

- EPA, 2011c )

.
2. 3 .4 Microorganisms
Soil microorganisms play a critical role in soil structure formation, decomposition of organic matter, toxin removal, nutrient cycling, most biochemical soil processes ( Garbeva et al. , 2004 ) and maintenance of soil structure and composition ( Rosen, 2010b )

. Compared to soil supporting crops, fallow soil has the lowest microbial mass and diversity ( Larkin, 2003 ) . Microorganisms suppress soil

- borne plant diseases and promote plant growth ( Doran et al. , 1996 ; Inceoglu et al. , 2013 )

. The main factor s affecting microbial population size and diversity include soil type (texture, structure, organic matter, aggregate stability, pH, and nutrient content), plant type (providers of specific carbon and energy sources into the soil), and agricultural manageme nt practices (crop rotation, tillage, irrigation and herbicide and fertilizer application) ( Garbeva et al. , 2004 ; Rosen, 2010d )

. Crop type also may play an important role in the type of soil microorganisms in soils ( Larkin, 2003 )

. Plant roots, including those of potato , release a variety of compounds into the soil creating a unique environment for microorganisms in the rhizosphere , whereby microorganisms may be attracted to and stimulated by th e roots ( Inceoglu et al. , 2013 )

. Microbial diversity in the rhizosphere may be extensive and differs from the microbial community in the bulk soil ( Garbeva et al. , 2004 )

. Larkin ( 2006 ) investigated th e effect of potato production on soil microbial communities over a period of three years. A two

- year rotation period appears to control soil

- borne disease. Potato soil microbial populations were lower than for several other crops, including canola , barley, and corn. Use of rotations also appeared to reduce the i ncidence and severity of black scurf, as well as reduced the number of misshapen tubers . Larkin ( 2006 ) suggested that activity and diversity of microbial populations were

n egatively correlated with the percentage of misshapen tubers.
In a study examining the abundance and structure of bacterial communities in a potato

- barley

- potato rotation, it was determined that the roots of all potato cultivars had positive effects on bac terial

32numbers in the soil, diversity and community structure of bacterial communities varied with time and season, and the composition of bacterial communities is linked to the specific requirements of different cultivars. Bacterial composition was poten tially related to tuber starch content, as well as specific fertilizers ( Inceoglu et al. , 2013 )

. Pathogenic microorganisms which are associated with diseases of potatoes , is discussed in S ection 2. 1 .2 , General Agronomic Practices , Disease Control

.
2. 3 .5 Biodiversity

Biodiv ersity refers to all plants, animals, and microorgani sms interacting in an ecosystem . Biodiversity provides valuable genetic resources for crop improvement ( Harlan, 1975 ; Wilson, 1988 ) , and also provides other functions beyond food, fiber, fuel, and income. These include pollin ation, genetic introgression, biological control, nutrient recycling, competition against natural enemies, soil structure, soil and water conservation, disease suppression, control of local microclimate, control of local hydrological processes, and detoxif ication of noxious chemicals ( Altieri, 1999 )

. The loss of biodiversity results in a need for costly management practices in order to provide these functions to the crop ( Altieri, 1999 )

. The degree of biodiversi ty in an agroecosystem depends on four primary characteristics: 1) diversity of vegetation within and around the agroecosystem; 2) permanence of various crops within the system; 3) intensity of management; 4) extent of isolation of the agroecosystem from natural vegetation ( Southwood and Way, 1970 )

. Agricultural land subject to intensive farming practices, such as that used in crop production, generally has low levels of biodiversity compared with adjacent natural areas ( Altieri, 1999 )

. Tillage, seed bed preparation, planting of a monoculture crop, pesticide use, fertilizer use, and harvest ing limits the diversity of plants and animals ( Lovett et al. , 2003 )

. Biodiversity can be maintained or reintroduced into agroecosystems through the use of woodlots, fencerows, hedgerows, and wetlands. Agronomic practices include intercropping (the planting of two or more crops simultaneously to occupy the same field), agroforestry, crop rotations, cover crops, no

tillage, composting, green manuring (growing a crop specifically for the purpose of incorporating it into the soil in order to provide nutrients and organic matter), addition of organic matter ( e.g., compost, g reen manure, animal manure), hedgerows and windbreaks ( Altieri, 1999 )

. Because potatoes are grown throughout regions of the United States , there is a large diversity of plants and animals that inhabit the areas surrounding the potato fields. These include the weeds discussed in Section 2. 1 .2 , Agronomic Practices, Weed Control, and animals in Section 2. 3 .1 , Animal Communities.

332.4 Human and Animal Health

Humans are either consumers of potato and products derived from it, or are wor kers who produce potato crops

. Under the FFDCA, it is the responsibility of food and feed manufacturers to ensure the products they market are safe and properly labeled. Food and feed derived from GE potato must be in

c ompliance with all applicable legal and regulatory requirements. GE organisms used for food and feed may undergo a voluntary consultation process with the FDA prior to release onto the market. Although a voluntary process, thus far all applicants who wis h to commercialize a GE variety that will be included in the food supply have completed a consultation with the FDA. In a consultation, a developer who intends to commercialize a bioengineered food meets with the agency to identify and discuss relevant saf ety, nutritional, or other regulatory issues regarding the bioengineered food and then submits to FDA a summary of its scientific and re gulatory assessment of the food

. FDA evaluates the submission and responds to the developer by letter. Simplot submitt ed a letter of consultation on February 12, 2013 , which FDA is still reviewing ( BNF No. 141)

. As noted by the National Research Council (NRC), unexpected and unintended compositional changes arise with all forms of genetic modification, including both conv entional hybridizing and genetic engineering ( NRC, 2004 )

. Genetic modification, as a source of uncertainty, is comm on to all forms of plant breeding. The NRC also noted that at the time, no adverse health effects attributed to genetic engineering had been documented in the human population. Reviews on the nutritional quality of GE foods generally conclude that there a re no significant nutritional differences in conventional versus GE plants for food or animal feed ( Faust, 2002 ; Flachowsky et al. , 2005 )

.
2.4.1 Consumer Hea lth
The potato is the world’s number one non

- grain food commodity ( FAO, 2008 ) . Potatoes are high in nutrients and at least twelve essential vitamins, especially vitamins B and C, and minerals such as iron, potassium, and zinc ( Arvanitoyannis et al. , 2008 ; FAO, 2008 ; Bushway, 20 10 ) . They have the highest protein content (around 2.1 percent on a fresh weight basis) in the family of root and tuber crops. As a low

- fat source of carbohydrates, potatoes can be instrumental in providing a solution to long

- term problems of worl d hunger ( Bushway, 2010 )

. Because of their high sugar and starch content and resulting high glycemic index, consumption of potatoes by persons with diabetes or similar conditions may need to eat potatoes sparingly.
U.S. per capita potato consum ption is summarized in Table 6

.



### Table 6 . U .S. Per Capita Potato Consumption 201 1

Fresh Processing All

34Market Canned Frozen Chips Dehydrated Total Processing Potatoes

2011p 34 1 48 17 11 76 110

Source: ( NPC, 2012 )

. Units are in lbs./person/year. Individual components may not add up to the total due to rounding and 2011 values are preliminary

.

Toxins and Allergens in Potato

Potatoes contain two classes of toxins and/or allergens: glycoalkal o ids and patatins. Acryl amide is a toxic compound formed in cooking potatoes at high temperatures, such as baking and frying.
Glycoalkaloids are well

- known , naturally

- occurring compounds that are present in all potatoes that likely

serve a s a defense mechanism against predator attack

. These compounds are concentrated in foliage, flowers and sprouts, although glycoalkaloids are present in lower concentrations in other parts of the plant, including tubers. For food safety purposes, an upper limit for glycoalkaloid content of 20

m illigrams per 100 grams of potato is generally accepted. Concentrations exceeding this level are potentially poisonous to humans and livestock

. H arvested tubers exposed to light ( Sinden, 1987 )

. Concentrations exceeding this are potentially poisonous to humans and livestock

. Light exposure to h arvested tubers can increase glycoalkaloid content in potatoes, and may result in green areas of coloration on potato skins ( Sinden, 1987 ; IPC, 2010 )

.
Patatin s are a family of protein s comprising 30 to 40 percent of the soluble protein in potatoes ( Mignery et al. , 1988 ) . Allergic reactions to cooked potatoes are considered to be very uncommon and were reported only in children ( De Swert et al. , 2002 )

. P atatin was identified as the major alle rgen involved in this reaction ( De Swert et al. , 2007 )

. Individuals who are allergic to patatin would need to avoid eating potatoes b ecause potato protein naturally contains a relatively large proportion of patatin.
Of greatest significance to human health is the toxic compound acrylamide, which is a known carcinogen of rodents and a probable human carcinogen ( WHO

- IARC, 1994 ; NTP, 2011 ; Chawla et al. , 2012 ; Halford et al. , 2012a )

. In particular, risk of endometrial and ovarian cancer appears to increase with increased acrylamide intake ( Pedreschi, 2009 ) . Acrylamide is also regarded as a mammalian cell mutagen, wherein very low dosages of the compound ca n damage chromosomes ( Chawla et al. , 2012 ) . Acrylamide has also been reported to be a cumulative neurotoxin ( Friedman, 2003 )

. Acrylamide is formed in potatoe s which are cooked at high temperatures, such as baking or frying. In 2002, Swed ish researchers demonstrated that acrylamide forms when starchy foods, such as potatoes and breads, are heated at high temperatures, but not in unheated or boiled foods ( Tareke et al. , 2002 ; Halford et al. , 2012a ) . Therefore, even though dietary exposure to acrylamide is measurable, it is not a natural compositional component of unheated foods derived from plants. Acrylamide forms during the Maillard reaction ( Martins et al. , 2000 ) which is a reaction at high temperatures (such as frying French

35fries) between certain sugars such as gluco se and fructose (reducing sugars) and asparagine (an amino acid) that are naturally present in the food ( FDA, 2009 )

. In addition, prolonged heating time increases acrylamide content, whereas higher moisture content reduces ac rylamide content ( Kotsiou et al. , 2013 )

. Maillard reaction products, which affect the flavor and texture of the cooked food, are formed by a chemical reaction between an amino acid and a reducing sugar ( Halford et al. , 2012b ) . Oxidation of the free amino acid asparagine, a major amino acid in potatoes and cereals ( Mottram et al. , 2002 ; Chawla et al. , 2012 ) , is the main source of acrylamide when starchy foods are baked or fried ( Stadler et al. , 2002 ; Friedman, 2003 ; Halford et al. , 2012a ; Kotsiou et al. , 2013 ) . Color of cooked potato products such as potato chips has been found to correlate well with acrylamide formation: the darker the color, the higher the greater the acrylamide concentration ( Arvanitoyannis et al. , 2008 ; Pedreschi, 2009 ; Halford et al. , 2012a ; Kotsiou et al. , 2013 )

. Important variables leading to acrylamide formation and affecting acrylamide concentration in cooked potatoes include reducing sugar content, processing/cooking temperature and method, cooking/processing time, moisture content, and additives ( Halford et al. , 2012a ; Kotsiou et al. , 2013 ) . In turn, concentrations of sugars and amino acids are influenced by cultivar, fertilizers, climate, and storage conditions ( Pedreschi, 2009 )

. It is estimated that potato chips and fried potato products such as French fries are responsible for about 1/3 of the human dietary exposure to acrylamide ( Ch awla et al. , 2012 )

. Acrylamide is also present in other foods such as coffee, some breads, biscuits, gingerbread, and processed onion mix and dip mixes. Smoking may contribute to human exposure to acrylamide ( Friedman, 2003 ; Chawla et al. , 2012 ; Kotsiou et al. , 2013 )

. For all of these reasons, the discovery of acrylamide in cooked potato products has raised concerns throughout the potato processing industry, as well as among consumers. The FAO/WHO Expert Committee on Food Additives has recommended that dietary exposure to acrylamide should be reduced ( FAO/WHO, 2011 ) . Perhaps because children consume more acrylamide

- laden products such as French fries and potato chips, their exposure to the ch emical is greater than for adults ( Friedman, 2003 ; Halford et al. , 2012b )

. The State of California listed acrylamide as a potential carcinogen under Pr oposition 65 in 1990 and established a No Significant Risk Level (NSRL) of 0.2 μg/ day ( CEPA

- OEHHA, 2005 ) . Subsequent to the discovery of acrylamide in cooked foods, this NSRL was revised to 1.0 μg/day ( CEPA

- OEHHA, 2005 )

. FDA has recently released draft guidance for the food industry to reduce acrylamide in foods ( FDA, 2013a )

. Proposition 65 requires that food manufacturers warn consumers about the dangers of acrylamide in their products. In 2005, the State of California sued Frito

- Lay, Kettle Foods and Lance, Inc. for failing to provide s uch warnings. In the settlement, the potato chip manufacturers agreed to reduce the acrylamide in their products to 275 ppb, low enough to avoid the Proposition 65 warning. These three companies also agreed to pay close to $2M in penalties and court cost s. The potato processing industry now has a strong financial incentive to reduce the levels of acrylamide in their retail products.

362.4.2 Worker Health
Worker hazards in farming are common to all types of agricultural pro duction, and include hazards from equipment and plant materials. Pesticide application represents the primary exposure route to pesticides for farm workers. Workers engaged in potato production may encounter insecticides, herbicides, fungicides or fertilizers that may pose a worker healt h or safety risk , unless used in accordance with the US

- EPA established agriculture

- specific requirements in the Worker Protection Standard (WPS) (40 CFR Part 170) that protect workers from the hazards of chemical exposure. The WPS offers protections to mo re than two and a half million agricultural workers who work with pesticides at more than 560,000 workplaces on farms, forests, nurseries, and greenhouses. The WPS contains requirements for pesticide safety training, notification of pesticide applications, use of personal protective equipment, restricted entry intervals following pesticide application, decontamination supplies, and emergency medical assistance. The Occupational Safety and Health Administration require all employers to protect their employee s from hazards associated with agricultural chemicals. The EPA pesticide registration process, however, involves the design of use restrictions that if followed have been determined to be protective of worker health.
A potato field is a highly managed envi ronment which incorporates the use of agricultural chemicals, including herbicides and insecticides. Pesticides are used on most potato acreage in the U

. S

. , and changes in acreage, crops, or farming practices can affect the amounts and types of pesticides used and thus the risks to workers. Worker safety precautions and use restrictions are noted clearly on pesticide registration labels. Growers are required to use pesticides consistent with the application instructions provided on the EPA

- approved pestici de labels. These restrictions provide instructions as to the appropriate levels of personal protection required for agricultural workers. These may include instructions on personal protective equipment, specific handling requirements, and field reentry pro cedures ( see, e.g. ( Carroll and Robinson, 2006 ) )

.
2. 4.3 Animal Feed

Potatoes used as livestock feed accounted for approximately 1 % of a ll potatoes produced in the United States in 2012 (see Table 7 ). This quantity includes potatoes sold specifically as livestock feed and potatoes used as livestock feed on farms where the crop was grown. It does not include the potato waste t hat was used for livestock feed ( USDA

- NASS, 2013a )

. Use of potatoes for livestock feed is generally dependent on quality and price : for example, when potatoes are low in both price and quality, more of the crop tends to be used for livestock feed. Prices for feed are usually the lowest of all potato usage categor ies ( Guenther, 2010c )

.

37

### Table 7

. U.S. 2012 Potato Utilization

Utilization Item CWT (1,000) (% of potatoes harvested )

Sales

– fresh and processing
Table stock (fresh) 118,535 (25.6%)

Processing
Chips and shoestrings 56,349 (12.2%)
Dehydrated (except starch and flour) 50,559 (10.9%)

Frozen French fries 144,910 (31.3%)
Other frozen products 20,912 (4.5%)
Canned products 1,764 (0.4%)
Other canned products (hash, stews, soup) 695 (0.2%)
Starch, flour and other 8,031 (1.7%)

Total processing 282,220 (61.0%)

Other sales

Livestock feed 4,080 (0.9%)

Seed 23,706 (5.1%)

Non

- sale
Seed used on farms where grown 3,286 (0.7%)
Household and feed use on farms where grown 1,583 (0.3%)

38Utilization Item CWT (1,000) (% of potatoes harvested )
Shrinkage and loss 28,356 (6.1%)

Total Production 462,766

Source: ( USDA

- NASS, 2013a )

Potatoes constitute at least part of the diet for several domestic animals, including cattle, horses, pigs, and poultry. The recommended rate of feed is approximately 25

- 40 lb

. potatoes/1,000 lb

. live weight, but can vary with the ty pe of animal. Potatoes are considered to be a palatable feed, and are high in moisture content, but are not as nutritious as grain or corn silage (e.g., it takes 400

- 500 lb s. of potato es to provide the same nutritive value as 100 lb s. of grain ( Cor bett, No Date )

. Feed does not include the leafy green f oliage of potato plants since flowers, sprouts, and foliage has abundant glycoalkaloids, which are potentially poisonous for livestock ( Sinden, 1987 )

. Similar to the regulatory control for direct human consumption of potato under the FFDCA, it is the responsibility of feed manufacturers to ensure that the products they market are safe and properly labeled. Feed derived from GE potato must comply with all applicable legal and regulatory requirements, which in turn protects h uman health. To help ensure compliance, GE organisms used for feed may undergo a voluntary consultation process with FDA before release onto the market, which provides the applicant with any needed direction regarding the need for additional data or analy sis, and allows for interagency discussions regarding possible issues. Consequently, any uncertainty in this area is addressed during an FDA inquiry process.
Although a voluntary process, thus far all applicants who wish to commercialize a GE variety tha t will be included in the food supply have completed a consultation with the FDA. In a consultation, a developer who intends to commercialize a bioengineered food meets with the agency to identify and discuss relevant safety, nutritional, or other regulat ory issues regarding the bioengineered food and then submits to FDA a summary of its scientific and re gulatory assessment of the food . FDA evaluates the submission and resp onds to the developer by letter

. Simplot submitted a letter to FDA on February 12, 2 013, whi ch FDA is currently reviewing (BNF No. 141)

.
2. 5 Socioeconomics
As part of an evaluation of impacts on the h uman environment , NEPA requ ires consideration of economic and social effects (40 CFR 1508.8) , whether direct, indirect, or cumulative. However, under

39CEQ regulations (40 CFR 1508.14) , “

. . . economic or social effects are not intended by themselves to require preparation of an environmental impact statement .”
The following s ocioeconomic factors are considered i n this EA : the interaction of social and economic factors that affect agricultural production and products, including farm income and employment, crop production expenses, crop value and trade

.
2. 5 .1 Domestic Economic Environment
Potatoes contribute approximately 15 % of farm sales receipts for vegetables, making potatoes the leading vegetable crop in the United States ( USDA

- ERS, 2012b ) . The total value of U.S. potato production in 2012 was $3.9 billion, the average yield was 409 CWT/acre and the average price received was $7.26/ cwt ( USDA

- NASS, 2012c ) . U nlike true commodity crops such as corn and soybeans, most potatoes are grown for a specific market. As shown in Table 8 , the Russet Burbank and Ranger Russet are primarily used for fries, and the Atlantic, “H”, and “G” varieties are primarily used for ch ips. Atlantic is the standard for making potato chips from the field or from very short storage ( PAA, 2009b ) . Any of these varieties can also be sold on the fresh market. On the fresh market, Russet Burbank and Ranger Russet potatoes are the standard for baking ( Pavek et al. , 1992 ; PAA, 20 09a ) . Other varieties are used for canning and are well

- suited for boiling. There are thousands of potato varieties, som e intended for very small markets ( FAO, 2008 )

. Uses for all potato varieties combined in the United States are summarized in Table 8 . Specific varieties are not grown for the dehydration market or for livestock feed; rather, food

- grade potatoes considered unsuitable for their intended fresh or other processing markets are usually used for these purposes ( Guenther, 2010c ) . Because potato sales for livestock feed usually receive the lowest price, potatoes are not sold for livestock feed if other uses are available ( Guenther, 2010c )

.



### Table 8

. A Sample of U.S. Potato Varieties and their Uses

Variety 1 Use

Russet Burbank Boiling, baking, chipping, French frying
Ranger Russet Baking, French frying

Atlantic Fresh market, chipping

Kennebec Boiling, pan frying, chipping, French frying

Norland Boiling, French frying, chipping

40Yukon Gold Fresh market, boiling, baking, French frying

1 http://potatoes.wsu.edu/varieties/vars

- all.htm

Fresh market potatoes in North America can be classified broadly as russets, reds, yellows or whites based on skin color. Most eastern potato growers also are involved in packing; in the west, the businesses are usually separate. Recently, western growers have entered the packing business, often in partnerships or cooperatives wi th other growers ( Guenther, 2010a )

. Fresh potatoes may be shipped in refrigerated rail cars or tru cks to maintain a high standard of quality whereas frozen and dehydration processing typically occurs near potato production areas. The fragility of chips and the high cost of shipping low

- density products results in most chipping plants being located

nea r populated areas. Except for dehydrators, processors typically contract for most of their needs and buy the remainder on the open market. Some dehydrators segregate potatoes that are suitable for the fresh market, and then sell those on the fresh market , processing the rest. Others purchase off

- grade potatoes from fresh packers for processing ( Guenther, 2010b )

. Revenues and costs of potato production vary widely, depending on geography, growing conditions, the local economy, the type of potato, farm size, and other factors. For example, the 2011 per acre operating cost of growing Russet Burbank potatoes in s outhwestern Idaho, including on

- farm storage and fumigation, was $2,811 ( Patterson, 2011 ) . In the same year, the gross return per acre averaged $4,107.50, resulting in a net return of $1,297. When that same variety was grow n in south

- c entral Idaho, the 2011 per acre operating cost, including on

- farm storage and fumigation, was $2,56 0 ( Patterson, 2011 ) , and t he gross return per acre averaged $3681.25, result ing in a net return of $1,121.
Approximately 90 percent of U.S. potatoes are planted in the spring and harvested in the fall, and western states produce two

- thirds of the fall potatoes. The storage abiliti es of potatoes enable fall

season potato varieties to be sold in fresh or processing markets throughout the September

- August marketing year. Less than 10 percent of potatoes are harvested in winter, spring and summer; however, these potatoes meet specific market needs (e.g., new potatoes) and tend to yield higher prices than fall potatoes ( USDA

- ERS, 2012b )

. Sale values per acre are normally highest for the winter crop and lowest for fall potatoes, but varies widely among the producing states. Prices for fresh potatoes are usually higher than prices for processi ng potatoes due to crop

- quality standards. Domestic potato prices may vary not only in response to changes in weather, yield or demand, but also to changes in supply from imported potatoes and potato products. If a large quantity of frozen French fries e nters the country, U.S. potato processors may cut back on contracts for processing potatoes, which would be diverted to the fresh market. Fresh market prices would likely fall as a re sult ( USDA

- ERS, 2012b )

.

41Not all potatoes are sold for food. The largest non

- sales category is “shrinkage and loss”, which

accoun ts for the water weight loss and loss due to respiration during storage. Also in this category are potatoes that do not meet market quality standards due to decay, bruising, greening, sprouting and disease. Crops that suffer frost damage also are added t o this category ( Guenther, 2010c )

. Potato production requires numerous expenditures, including for specialized machinery. The largest conventional operating cost items are fertilizer, chemicals and pesticides, storage and seed potatoes. Fertilizer and seed accounted for 25 percent of tota l production costs in eastern Idaho in 2007 ( Patterson, 2010 ) . Potato production costs for irrigation in the western United State s ranges between $1,500 and $3,500 per acre ( Patterson, 2010 ) . Costs do not stop accumulating at harvest unless the potatoes are sold out of the field. Additional costs are incurred to store potatoes.
For those producing organic potatoes, an organic production system is required in addition to a relatively long crop rotation to minimize pest problems. Profitability margins differ between organic farm sizes, but a study conducted in southern Idaho indicated that net returns over variable costs for a small farm (30

- 50 acres) with 100% organic premiums is $1,026/acre and $1,148/acre for a large farm (100

- 120 acres) ( Painter et al. , 2010 ) . Smaller farms have higher operating costs as a result of smaller, less efficient machine ry, and their machine hours for potato production are more than double the hours on a large organic farm. While larger farms reduce labor expenses by half with more efficient machinery, they do have an increase in capital costs. Organic potato growers fa ce challenges, including growing sufficient fall cover crops to supply soils with additional nitrogen, but profit margins for organic potatoes have the potential to exceed those for conventional potatoes if these and other challenges are addressed ( Painter et al. , 2010 )

. In general, post

- harvest losses are a significant part of the production costs of fruits and vegetables, and may reach as high as 50% ( Martinez and Whitaker, 1995 ; Llorente et al. , 2011 ) . Browning of fruits and vegetables negatively affects consumer acceptance because of altered appearance and perceived nutritio nal deficit ( Llorente et al. , 2011 )

. Specifically, potato growers can lose up to 20% of income through potato injury at harvest ( Preston, 2010 ) . The potato industry, therefore, has a vested interest in minimizing these losses.
Black spot bruise is typically caused by mechanical injury to tubers during harvest, handling, storage, or processing such as scuffing and cracking o f the skin ( Dirks

- Hofmeister et al. , 2013 )

. Injury leads to a bluish

- grey to black d iscoloration of internal tuber tissue ( Stremmel et al. , 2010 ) . Bruising symptoms do not appear until 3 hours to 24 hours following mechanical impact, and are not visible until the skin is removed from the tuber ( Stremmel et al. , 2010 ; Urbany et al. , 2011 )

. Because bruising cannot be observed until the potato skin is removed, it is more difficult to identify damaged tubers, and makes conventional means of breeding to eliminate this trait more problematic ( Urbany et al. , 2012 )

. Physical tuber properties, such as tissue stiffness and elasticity, affect transfer of the impa ct energy to the tuber and may affect susceptibility of the tuber to bruising. For example, if potato tissue does not crack during injury, the force of the impact is more evenly distributed throughout a larger area of the

42tuber, which results in greater c hanges to metabolism, and, hence more bruising ( Stremmel et al. , 2010 )

. Therefore, bruising susceptibility varies widely among potato cultivars ( Stremmel et al. , 2010 ) . To a large extent, susceptibility is dependent on multiple genetic traits, as well as on maturity of tubers and environmental factors ( Urbany et al. , 2011 )

. Potato genotypes with high tuber starch content are more susceptible to bruising ( Urbany et al. , 2012 )

. The chemical basis for black spot bruising lies in the cellular release of phenolic compounds, normally compartmentalized in the vacuoles, following injury ( Tran et al. , 2012 )

. The phenolic compounds are converted to o
- phenols and o
- quinones by the enzyme polyphenol oxidase (PPO) ( Dirks

- Hofmeister et al. , 2013 ) . These quinoids auto

- oxidize, forming melanin, leading to blackened tissue which is called enzymatic browning and is undesirable in processed potato product ( Hunt et al. , 1993 ; Steffens, 1994 ; Stremmel et al. , 2010 ; Llorente et al. , 2011 ; Vitti et al. , 2011 )

. Oxidative browning reactions generally cause deterioration in food quality by changing nutrit ional and organoleptic properties, and can involve changes in texture and flavor as well as color ( Yoruk and Marshall, 2003 ) . The side chains of essential amino acids in plant proteins may interact with quinones, leading to a reduction in nutritional quality ( Yoruk and Marshall, 2003 )

. Degree of discoloration is strongly related to PPO act ivity ( Urbany et al. , 2011 )

. Polyphe nol oxidase expression is mediated by a multi

- gene family in potato ( Thygesen et al. , 1995 ; Llorente et al. , 2011 )

. Storage temperatures also affect the likelihood of black spot bruise ( Preston, 2010 ) since increased temperature heightens PPO activity ( Yoruk and Marshall, 2003 ; Vitti et al. , 2011 )

.
2. 5 .2 Trade Economic Environment
U.S. and global trade are greatly affected by the growth and stability of world markets, including changes in world population, economic growth, and income. Other factors affecting agricultural trade are global supplies and prices, changes in exchange rates, government support for agriculture, and trade protection policies.
U.S. farmers and agricultural firms rely heavily on export markets to sustain prices and revenues because productivity of U.S. agriculture increases fast er than the demand for domestic food and fiber. U.S. food imports have increased with the corresponding increase in demand for greater diversity in the food supply. U.S. consumers benefit from imports because imports expand food variety. This also tends to stabilize year

- round supplies of and prices for fresh fruits and vegetables.
U.S. exports of potatoes and potato products have grown 133 % in value and 79 % in volume during the last 10 marketing years ( Board, 2013 ) . Frozen potato products comprise 60 % of the U.S. potato exports. During the 2012/ 2013 market year (September

- August), U.S exports of potatoes and potato produ cts totaled $1.6 billion

— up from $1.4 billion in the previous market year ( USDA

- ERS, 2013 )

. Exports t o target markets were led by an increase in shipments to Mexico, South Korea, Malaysia, and Vietnam. During the 2012/ 2013 market year, Canada was the largest market for chips while Japan was the largest market for frozen potato products and dried, flour, and meal potato products ( Board, 2012 ;

43USDA

- ERS, 2013 ) . Mexico provides the United States with the largest market for exporting potato flakes and granules and is the second largest market destination for frozen potatoes ( Board, 2012 ; USDA

- ERS, 2013 )
U.S. potato and potato product exports are expected to grow during the upcoming marketing year ( Board, 2013 ) . Growth rates wi ll depend upon economic growth in the markets and the supply and price of competitor products. The United States will facilitate the growth of the export market by continuing to gain new market access, as just occurred for fresh table

- stock to the Philipp ines ( Board, 2013 )

.
2. 5 .3 Organically Certified Economic Environment
In the United States, products produced using only speci fic methods and certified under the USDA AMS N ational Organic Program (NOP) definition of organic farming can be marketed and labeled as “organic ” ( USDA

- AMS, 2010 ) . Organic certification is a process

- ba sed certification ; not a certification of the end product . T he certification process specifies and audits the methods and procedures by which the product is produced.

I n accordance with NOP, each year an accredited organic certifying agent must review an operation. This must include a review of its organic system plan and record

- keeping practices, and an on
- site inspection of the production area(s). Organic growers must maintain records to show that production and handling procedures comp l y with USDA organic standards.
Section 205.105 of the regulations identifies “ Allowed and prohibited substances, methods, and ingredients in organic production and handling.
“To be sold or labeled as ‘100 percent organic,’ ‘organic,’ or ‘made with organic’ (specified ingredients or food group(s)),” the product must be produced and handled without the use of: . . . (e) Excluded methods . . . .”

E xcluded methods identified at 7 CFR Section 205.2 , are defined as follows:
“A variety of methods used to genetical ly modify organisms or influence their growth and development by means that are not possible under natural conditions or processes and are not considered compatible with organic production. Such methods include cell fusion, microencapsulation and

macroenca psulation, and recombinant DNA technology (including gene deletion, gene doubling, introducing a foreign gene, and changing the positions of genes when achieved by recombinant DNA technology). Such methods do not include the use of traditional breeding, co njugation, fermentation, hybridization, in vitro fertilization, or tissue culture.”
Organic farming operations, as described by the NOP, are required to have distinct, defined boundaries and buffer zones to prevent unintended contact with excluded methods from adjoining land that is not under organic management. Organic production operations must also develop and maintain an organic 44production system plan approved by their accredited certifying agent. This plan enables the production operation to achieve and document compliance with the National Organic Standards, including the prohibition on the use of excluded methods ( USDA

- AMS, 2010 )

. Common practices organic growers may use to exclude GE products inc l ude planting only organic seed, planting earlier or later than neighboring farmers who may be using GE crops , so that the crops will flower at different times, and employing adequate isolation distances between organic and neighboring fields to minimize the chance for pollen exchange between fields ( NCAT, 2003 ) . Although the n ational

o rganic s tandards prohibit the use of excluded methods, they do not require testing of inputs or products for the presence of excluded methods. The presence of a detectable residue of a product of excluded methods alone does not necessarily constitute a violation of the n ational o rganic standards ( USDA

- AMS, 2010 ) . The current NOP regulations do not specify an acceptable threshold level for the adventitious presence of GE materials in an organic

- labeled product. The unintentional presence of the products of excluded methods will not affect the status of an organic product or o peration if excluded methods were used and reasonable practices were implemented to avoid contact with products of excluded methods as detailed in their approved organic system plan ( Ronald and Fouche, 2006 ; USDA

AMS, 2010 )

. Organic market and products
The organic sector is rapidly growing b oth in the United States and the EU. C onsumer purchases in these two regions made up 95 % of estimated world retail sales of organic f ood products in 2003 ( Dimitri and Oberholtzer, 2009 )

. Annual manufacturer survey results ( Organic Trade Association, 2011 ) , indicated that estimated U.S . organic food sales for 2010 were $26.7 billion. This represented a 7.7 % growth rate from the previou s year

. The market sector e xperiencing the highest growth rate during 2010 was organic fruits and vegetables, which increased 1 1.8 % compared with 2009 sales. The market share for o rganic fruits and vegetables was 11 % of all U.S. fruit and vegetable sal es ( Organic Trade Association, 2011 ) . Organic products represented approximately 4 % of total 2010 sales in the food and beverage sector ( Organic Trade Association, 2011 )

. Organic Potatoes

In 20 08 , 2.2 million cwt of organic potatoes were harvested, with a total sales value of almost $29 million ($13. 24 / cwt ) ( USDA

- NASS, 2012a )

. Prices for organic potatoes are typically substantially higher than the overall average conventional pot ato price, and probably reflect both the organic premium and the fact that most organic potatoes are sold fresh. Organic growers typically receive a significant price premium when they can sell their potatoes as organic ( Dufour et al. , 2009 ) ; however, that market is not al ways availa ble ( Esplin, 2009 ) . The organic potato market is not highly structured ( Dufour et al. , 2009 )

. At least one manufacturer produces organic potato chips ( Foods, 2009 )

.

453. ALTERNATIVES 

### This document analyzes the potential environmental consequences of a determination of nonregulated status of Simplot InnateTM p otato

. Two alternatives are evaluated in this EA: (1) no action and (2) determination of nonregulated status of event. APHIS has assessed the potential for environmental impacts for each alternative in the Environmental Consequences section.

3.1 No A ction Alternative: Continuation as a Regulated Article
Under the No Action Alternative, APHIS would deny the petition. Simplot Innate TM p otato and progeny derived from Simplot Innate TM p otato would continue to be regulated articles under the regulations at 7 CFR part 340. Permits issued or not ifications acknowledged by APHIS would still be required for introductions of Simplot Innate TM p otato and measures to ensure physical and reproductive confinement would continue to be implemented. APHIS choose s this alternative when there is a clear pest r isk, or if there is insufficient evidence to demonstrate the lack of plant pest risk from the unconfined cultivation of Simplot Inn ate TM p otato . This alternative is not the Preferred Alternative because a Plant Pest Risk Assessment (PPRA) found Simplot Inna te TM p otato is unlikely to pose a plant pest risk ( USDA

- APHIS, 2013a )

.
3.2 Preferred Alternative: Determination T hat Simplot InnateTM Potato I s No Longer a Regulated Article
Under this alternative, Simplot Innate TM p otato and derived progeny would no longer be regulated articles under the regulations at 7 CFR part 340. Permits issued or notifications acknowledged by APHIS would no longer be required for introductions of Simplot Innate TM p otato and progeny derived from this event. Under this alternative, growers may have fu ture access to Simplot InnateTM p otato and progeny derived from this event if the developer decides to commercialize Simplot InnateTM p otato.
This alternative meets the purpose and need to respond appropriately to a petition for nonregulated status when there is a determination of no pest risk. B ased on the PPRA conclusion that Simplot Innate TM p otato is unlikely to pose a plant pest risk (USDA

- APHIS, 2013a) , conferring nonregula ted status to Simplot Innate TM p otato is a response that is consistent with the plant pest provisions of the P lant P rotection A ct , the regulations codified in 7 CFR part 340, and the biotechnology regulatory policies in the Coordinated Framework.

3.3 Altern atives Considered But Rejected from Further Consideratio n
APHIS assembled a list of alternatives that might be considered for Simplot Innate TM p otato . The agency evaluated these alternatives, in light of the agency's authority, environmental safety, effica cy, practicality , and other concerns. APHIS rejected several alternatives based on the discussions summarized in this section

. 463.3.1 Prohibit Any Simplot InnateTM Potato from Being Released
In response to public comments stat ing a preference for GE organisms t o not enter the marketplace, APHIS considered prohibiting the release of Simplot Innate TM p otato , including denying any permits associated with the field testing. APHIS determined this alternative is not a reasonable alternative because APHIS found Simplot Innate TM p otato is unlikely to pose a plant pest risk ( USDA

- APHIS, 2013a )

. This finding is c onsistent with the PPA and EO 13563 . B ased on the findings and scientific data evaluated in the PPR A ( USDA

- APHIS, 2013a ) , u se of this potato is not expected to change t he risk of gene flow or weediness in comparison to other potato cultivars. It is not expected to change the range , area, and agronomic practices used in potato production (machine use and fertilizer application). Therefore, there is no basis in science for finding a plant pest risk, and consequently prohibiting the release of Simplot Innate TM p otato.
3.3.2 Approve the P etition in P art

Th e regulations at 7 CFR 340.6(d ) ( 3 ) ( i) state that APHIS may "approve the petition in whole or in part." In this alternative, APHIS considered partial deregulation where progeny would not be deregulated. Restrictions prohibiting future “gene stacking” ar e unlikely to reduce plant pest risks because these genes are not associated with pest risk (USDA APHIS, 2013a) , and may lead to a human health benefit

. As an alternative, this choice would merely delay agency decision making, and could be perceived as

cr eating an unnecessary competitive restraint in the economy . For these reasons, partial approval is not a reasonable alte r native.

3.3.3 Isolation Distance between Simplot Innate TM Potato and Non

- GE Potato Production and Geographical Restrictions
In response to public concerns of gene movement between GE and non

- GE plants, APHIS considered requiring an isolation distance separating Simplot Innate TM p otato from conventional or specialty potato production. Isolation distances may be useful when wind

- borne pollen is likely to disseminate genes long distances. Potato is not considered to be a wind

- pollinated crop (OECD, 1997b), so imposing an ineffective restriction makes this alternative unreasonable

. Further, an alternative based on requiring isolati on distances would be inconsistent with the finding that Simplot InnateTM p otato is unlikely to pose a plant pest risk ( USDA

- APHIS, 2013a )

. APHIS also considered geographically restricting the production of Simplot Innate TM p otato . The restrictions could be based either on the production locations of non

- GE potato in organic production systems , or production systems for GE

- sensitive markets , or in response to public concerns regarding possible gene movement b etween GE and non

- GE plants. The PPRA did not identify geographic differences associated with any identifiable plant pest risks for Simplot InnateTM p otato ( USDA

- APHIS, 2013a ) and found it will not exhibit a grea ter plant pest risk in any geographically restricted area. To restrict production locations when there is unlikely to be any productive value creates an ineffective

47restriction that makes this alternative unreasonable. Further, an alternative based on rest rictions to production locations would be inconsistent with the finding that Simplot InnateTM p otato is unlikely to pose a plant pest risk (USDA

- APHIS, 2013a).
Based on the foregoing, individual farmers m ay choose to geographically isolate their non

- GE pota to production systems from potato , or use isolation distances and other management practices to minimize gene movement among potato fields. This stance correctly places these burdens on those wishing to enter a specialty or niche market, rather than placing unsupportable regulatory controls on a plant variety that is unlikely to pose a plant pest risk. The likelihood of market penetration by plants with these genes is not a proper regulatory concern under APHIS authority. Whether these genes become incorporated into other varieties depends on market forces that APHIS cannot predict and are irrelevant to the APHIS finding of no pest risk. Info rmation to assist growers in making informed management decisions for Simplot Innate TM p otato is available from Association of Official Seed Certifying Agencies ( AOSCA, 2010 )

. 3.3.4 Requirement of Testing for Simplot InnateTM Potato
During the comment periods for other petitions for nonregulated status, some commenters requested USDA to require and provide testing for GE products in non

- GE production systems. APHIS notes there are no nationally

- established regulations involving testing, criteria, or limits of GE materia l in non

- GE systems. Such a requirement would be extremely difficult to implement and maintain even if it was within APHIS’s regulatory authority to establish this type of system

. The inability to implement and maintain this type of system makes this pot ential alternative unreasonable.
3.4 Comparison of Alternatives

Table 9 includes a summary of the potential impacts associated with selection of the alternatives evaluated in this EA . The potential environmental consequences are presented in Section 4 of this EA

.



### Table 9

. Summary of Issues of P otential Impacts and Consequences of A lternatives

Attribute/Measure Alternative A: No Action Alternative B: Determination of Nonregulated Status Meets Purpose and Need and Objectives No Yes

Unlikely to pose a plant pest risk Satisfied through use of regulated field trials Satisfied

– risk assessment ( USDA

- APHIS, 2013a )
Management Practices

48

### Table 9

. Summary of Issues of P otential Impacts and Consequences of A lternatives

Attribute/Measure Alternative A: No Action Alternative B: Determination of Nonregulated Status

Acreage and Areas of Potato Production Total commercial potato production has increased while land area dedicated to potato has decreased. Based on potato production trends and projections, potatoes will continue to be a major crop in the U.S. for the foreseeable future. Total acreage dedicated to potato is unlikely to change, but adoption of Simplot InnateTM p otato may reduce acreage dedicated to conventional potatoes.

Agronomic Practices Agronomic practices will remain the same as used currently. Unchanged from No Action Alternative

Pesticide Use Pesticides are currently used to control insects, nematodes, fungi, and weeds. Unchanged from No Action Alternative

Potato Seed Production Potato seed is primarily supplied by seed potatoes. Unchanged from No Action Altern a tive

Organic Potato Production Organic potato growers use practices and standards for production, cultivation, and product handling and processing to ensure that their products are not pollinated by or commingled with conventional or GE crops. Unchanged from No Action Alternative

Environment

49

### Table 9

. Summary of Issues of P otential Impacts and Consequences of A lternatives

Attribute/Measure Alternative A: No Action Alternative B: Determination of Nonregulated Status

Water Resources T he p r im a r y c a use of
a g r i c ultu ral non

- point source pollution is in crea s e d
s e dim e nt a tion fr om soil
er osion, w hi c h ca n int r odu c e s e d i m e nts, fer tili z er s, a nd p e sti c id e s to n ear b y l a k e s a nd st r e a ms. A g r o nomic p rac ti ce s s u c h a s c r op nut r i e nt
m a n a g e m e nt, p e st
m a n a g e m e nt, a nd c o ns er v a tion bu ffer s h e lp p r ot ec t w a t e r qu a li t y fr om a g r i c ultu r a l r uno f f. Water usage for irrigation would be expected to continue to increase. Unchanged from No Action Alternative

Soil Quality A g r onomic p r a c ti ce s su c h a s cr op t y p e , till a g e , a nd p e st
m a n a g e m e nt ca n a f f e c t soil qu a li t y

. G r o wer s w ill a dopt
m a n a g e m e nt p rac ti ce s to
a dd re ss th e ir s p ec i f ic n e e ds in p r odu c i n g potatoes. Erosion potential may continue to increase. Unchanged from No Action Alternative

Air Quality A gr i c u l tu r a l a c t i v i t i e s su c h a s b u r n i n g, till in g , h a r v e s t in g , sp r a y in g p e st i c i d e s , a n d fe r t i li z in g , in c l ud in g th e e mi s si o ns f ro m f a r m e qu i p m e n t , c a n d i r ec t l y a f fec t a i r q u a li t y

. Ae r i a l
a pp l i ca ti o n o f herbicides m a y i m p a c t a i r q u a l i t y f ro m d r i f t , d i f f u s i o n , a n d v o l a t i li z a t i on o f t h e c h e m i c a l s , a s w e l l a s m o t o r
v e h i c l e e m i ss i o n s f r o m a i r p l a n e s o r h e l i c o p t e r s. Unchanged from No Action Alternative

50

### Table 9

. Summary of Issues of P otential Impacts and Consequences of A lternatives

Attribute/Measure Alternative A: No Action Alternative B: Determination of Nonregulated Status

Climate Change A g r i c ultu re
- re l a t e d ac tiviti e s ar e rec o g ni z e d a s both di r e c t
sou rce s of g r ee nhouse g a s e s ( GHG s ) (e

. g ., e x h a ust fr om moto r i z e d e quipm e nt) a nd indi rec t sou r c e s (e

. g ., a g r i c ultu re
- r e l a t e d soil distu r b a n ce , f er tili z e r p r o du c tion. Unchanged from No Action Alternative

Animal Communities Potato fields may be host to many animal and insect species. Many of these animals are typically considered pests and may be controlled by the use of integrated pest management strategies

. Animals consuming Simplot InnateTM tubers may be exposed to increased levels of glutamine, but this is not expected to be detrimental.

Plant Communities Potatoes are a labor intensive, highly managed crop. Members of the plant community that adversely affect potato production may be characterized as weeds. Weed control is an important aspect of potato production. Potato g r o wer s use p r odu c tion p rac ti ce s to m a n a g e w e e ds in
a nd ar ound potato fields. In the un likely event of hybridization of Simplot InnateTM p otato with conventional varieties, resulting progeny may contain lowered polyphenol oxidase levels. However, this is not expected to be detrimental. Simplot InnateTM p otato is no weedier than conventional p otatoes.

Gene Flow Since potato is primarily vegetatively propagated, gene flow between cultivars is low. Volunteer potatoes would continue to need to be controlled, although their survival is low. Simplot InnateTM traits are not expected to increase weediness in potato.

51

### Table 9

. Summary of Issues of P otential Impacts and Consequences of A lternatives

Attribute/Measure Alternative A: No Action Alternative B: Determination of Nonregulated Status

Soil Microorganisms Abundance and diversity of soil microorganisms in and around potato fields is expected to remain as it is currently. Unchanged from No Action Alternative

Biological Diversity The biological diversity in potato fields is lower than in the surrounding habitats. Unchanged from No Action Alternative

Human and Animal Health

Risk to Human Health Glycoalkaloids and patatins would continue to pose a risk to human health. In the case of humans consuming high

temperature cooked potatoes, they would continue to be exposed to acrylamide. Glycoalkaloid and patatin exposure would continue. For humans consuming high

temperature cooked potatoes, acrylamide levels
c ou ld be reduced
a pproximately 6 0

- 70%, which would benefit human health.

Risk to Animal Feed Glycoalkaloids would continue to pose a risk to livestock if potato stems and foliage are fed to them, which is not likely. Unchanged from No Action Alternative.

Socioeconomic

Domestic Economic Environment Most potato production is used for food. Market utilization would likely continue as it is currently. Because of its potential human health benefits (lower acrylamide) and potential reduced wastage (low bruisi ng), Simplot InnateTM p otato may comprise a larger share of the domestic potato market , and may result in increased revenues

.

52

### Table 9

. Summary of Issues of P otential Impacts and Consequences of A lternatives

Attribute/Measure Alternative A: No Action Alternative B: Determination of Nonregulated Status

Trade Economic Environment U.S. potatoes and potato products will continue to play a role in global potato production, and the U.S. will continue to be a supplier in the international market. The foreign trade impacts associated with a determination of nonregulated status of Simplo t InnateTM potatoes are anticipated to be similar to the No Action Alternative. However, import of each specific trait requires separate application and approval by the importing country. If the Simplot InnateTM traits are approved by importing countries, i t may make up a larger percentage of potato import markets. Other Regulatory Approvals

U.S. FDA completed consultations, EPA tolerance exemptions and conditional pesticide registrations granted FDA is currently reviewing Simplot’s voluntary consultation submission of February 12, 2013.

Other countries Countries importing potatoes would continue to do so. Simplot would need to obtain regulatory approvals from any nations which plan to import Simplot InnateTM p otato. Compliance with Other Laws

CWA, CAA, EO s Fully compliant Fully compliant

534 ENVIRONMENTAL CONSEQ UENCES

4.1 Environmental Consequences
This analysis of potential environmental consequences addresses the potential impact to the human environment from the alternatives analyzed in this EA, namely taking no action and a determination by the agency that Simplot Innate TM p otato does not pose a p lant pest risk (Preferred Alternative)

. Potential environmental impacts from the No Action Alternative and the Preferred Alternative for Simplot Innate TM p otato are described in detail throughout this section. A summary of potential environmental impacts is presented in Table 9 (Section 3.4, Comparison of Alternatives). A cumulative effects analysis is presented for potentially affected environmental concern s . Certain aspects of this product and its cultivation would be no different between the alternative s: those instances are described below.
4.2 Scope of Analysis
Potential environmental impacts from the No Action Alternative and the Preferred Alternative for Simplot Innate TM p otato are described in detail throughout this section. An impact would be any change, positive or negative, from the existing (baseline) conditions of the affected environment (described for each resource area in Section 2.0). Impacts may be categorized as dire ct, indirect, or cumulative. A direct impact is an effect that results solely from a proposed action without intermediate steps or processes. Examples include soil disturbance, air emissions, and water use. An indirect impact may be an effect that is re lated to but removed from a proposed action by an intermediate step or process. Examples include surface water quality changes resulting from soil erosion due to increased tillage, and worker safety impacts resulting from an increase in herbicide use.

A cumulative effects analysis is also included for each environmental issue. A cumulative impact may be an effect on the environment which results from the incremental impact of the proposed action when added to other past, present, and reasonably foreseeab le future actions. Examples include breeding Simplot Innate TM p otato with other deregulated events. If there are no direct or indirect impacts identified for a resource area, then there can be no cumulative impacts. Cumulative impacts are discussed in Sec tion 5.
Where it is not possible to quantify impacts, APHIS provides a qualitative assessment of potential impacts. Certain aspects of this product and its cultivation may be no different between the alternatives; those are described below.
Although the preferred alternative would allow for new plantings of Simplot Innate TM p otato to occur anywhere in the U.S., APHIS will limit the environmental analysis to those areas that currently support potato production.

544.3 Agricultural Production of Potato

4.3 .1 Acreage and Area of Potato Production

Acreage in potato production decreased in recent years, whereas potato yields increased dr amatically

. Potato acres harvested ranged between 1.0 and 1.5 million acres since 1951, with highs of 1.5 million in 1953, 196 6 and 1967 and lows of 1.0 million in 2008, 2009 and 2010 in the United States (USDA NASS 2012). Per

- acre yields, which averaged 397 cwt per acre in 2011 and 401 cwt per acre in 2012 increased eight

- fold since the early 1900s and doubled since the early 1 960s ( USDA

- NASS, 2013b )

. No Action Alternative: Acreage and Area of Potato Production USDA projects potato production will increase by 4.6 % between 2012 and 2021 ( USDA, 2012 ) . Based upon historical trends in productivity, this increase in supply is unlikely to result in an increase in potato acreage. Therefore, under the No Action alternative , agricultural land used for potato production is expected to remain at approximately the same a s at present.
Preferred Alternative: Acreage and Area of Potato Production If APHIS c hooses th e P referred A lternative, some of the Simplot InnateTM p otato events may become commercially available to the general public. Growers who now purchase conventional varieties of Russet Burbank, Ranger Russet and Atlantic potato seed would have the o ption of purchasing the Simplot InnateTM varieties instead of their conventional counterparts. With the reduction in black spot bruising and lower levels of reducing sugars, the Ranger Russet may gain more market share, partially replacing the Russet Burbank. The lower levels of reducing sugars in the Atlantic potato may result in increased market share for that variety, as well.
However, the introduction of these varieties is not expected to have an impact on overall demand for potatoes. As describe d in the petition ( Simplot, 2013b ) , the agronomic characteristics of the ten Simplot Innate TM events are essentially the same as their conventional counterparts, and therefore would be grown in the same way as their conventional counterparts. The ten Simplot Innate TM p otato events do not possess traits that would allow t hem to be grown in areas other than those where their conventional counterparts are grown. T herefore, under the Preferred A lternative, acreage dedicated to potat o would remain about the same.
Simplot’s data demonstrate no differences in morphological char acteristics and agronomic requirements between Simplot InnateTM p otato and other potato cultivars ( Simplot, 2013b ) and is not likely to change land acreage or any cultivation practices for potato production. It is expected that similar agronomic practices commonly utilized in commercially available potato cultivars would also be used by growers of Simplot Innate TM p otato

.

554.3 .2 Agronomic Practices

No Act i on Alternative: Agronomic Practices If APHIS chooses the No Action alternative, general production practices are expected to continue as they are now.

Preferred Alternative: Agronomic Practices The agronomic evaluation of the ten Simplot Innate TM p otato events is summarized in Section 7 of the petition, with details provided in Appendix 6; analysis of disease susceptibility is presented in petition Appendix 8 ( Simplot, 2013a ) . Since all ten Simplot Innate TM p otato events are intended fo r fry and chip production, agronomic evaluations were conducted in geographically distinct sites that represent most of the main production areas for potatoes destined for fry and chip production in the U nited States ( Simplot, 2013b ) . The agronomic practices and pest control measures employed were location

- specific and typical for potato cultivation. They were recommended by both regional potato extension specialists and field agronomists including soil preparation, fertilizer application, irrigation, cultivation and pesticide

- based control methods. Events and untransfo rmed varieties received identical inputs and treatments at each site. The following characteristics were evaluated over multi

- year trials: time to emergence, vigor, leaf size, leaf curl, vine maturity, disease susceptibility, insect damage, yield and spec ific gravity.
In these studies, five events (F37, E12, E24, G11 and H37) exhibited statistically significant increases in plant vigor, but the relative difference among the events was small. Five events (F10, F37, E24, G11 and H37) demonstrated significa nt reductions in total yield. There was no obvious correlation between decreased yield and increased disease or pest stress except possibly for event G11. Regardless of the cause, the potential for reduced yield is expected to impact market acceptability of varieties with these genes, and the data do not suggest reduced yield is correlated with increased pest risk ( USDA

- APHIS, 2013a )

. These trials indicated that no changes to current agronomic practices will be needed to grow the potatoes, thus the incorporated traits are not expected to affect agronomic practices. All events considered for deregulation were selected to exhibit comparable phenotypic characteristics to the control varieties when grown using stand ard industry practices. There were no differences in disease susceptibility that would require additional treatments, nor did the potatoes have different nutrient requirements that would alter fertilizer programs. Planting, cultivation, management and ha rvesting processes were not affected by the incorporated traits.

APHIS did not identify any significant changes to agricultural or cultivation practices (e.g. pesticide applications, tillage, irrigation, harvesting, etc.) that would result from adoption of the GE crop; therefore, no impact on plant diseases or pests or their management is likely to occur ( USDA

- APHIS, 2013a )

.

56Based on these analyses, i f APHIS chooses the preferred Alternative, there would be no exp ected differences in general agronomic practices than if the No Action alternative is chosen.

4.3 .3 Potato Seed Production

No Act i on Alternative: Potato Seed Production If APHIS chooses the No Action Alternative, potato seed production is expected to continue as it is currently.

Preferred Alternative: Potato Seed Production Since APHIS has determined that agronomic practices will be the same if the petition is approved ( USDA

APHIS, 2013a ) , selection of the Pr eferred Alternative is not expected to result in any changes in potato seed production.

4.3 .4 Organic Potato Production
No Action Alternative: Organic Potato Production In the United States, only products produced using specific methods and certified under the USDA’s Agricultural Marketing Service (AMS) National Organic Program (NOP) definition of organic farming can be marketed and labeled as “organic” ( USDA

- AMS, 2010 ) . Organic certification is a process

- based certification, not a certification of the end product; the certification process specifies and audits the methods and procedures by which the product is produced.
The organic sector is rapidly growing both in the U.S. and the European Union (EU). Together, consumer purchases in these two regions made up 95 percent of estimated world retail sales of organic food products in 2003 ( Dimitri and Oberholtzer, 2005 ) . In 2009, world retail sales of organic products were estimated to be on the order of $54.9 billion (USD), up from $50.9 billion in 2008 ( Organic Moni tor, 2006 )

. If APHIS chooses the No Action Alternative, organic potato production is expec ted to continue, but trends in production may be affected by unpredictable variables such as d emand for both fresh and processed organic potatoes, overseas comp eti tion and production costs.
Preferred Alternative: Organic Potato Production Practic es Potato cultivar selection and breeding practices are similar between organic and conventional potato production. Risks to organic growers would be most likely to occur with accidental mixing of planting material or of potatoes in farming, transportation, or processing cha nnels. These risks are the same as those that organic growers already experience when keeping their organically grown potatoes separate from potatoes grown with conventional methods. Because potatoes are clonally propagated, the risk of affecting seed sup plies through cross

- pollination is negligible. Organic farmers routinely plant organic seed potato material and any incidence of cross

- pollination in production fields will not affect the harvested potatoes. 57If APHIS chooses the Preferred Alternative, o rganic growers would not be expected to modify production practices, and so no impacts to organic potato production would be expected.
Some organic potatoes are grown in the same areas as conventional potatoes and some are grown in more isolated regions. Based on USDA data, organic potato acreage from 1997 to 2008 showed a general increasing trend ranging from a low of 4,335 acres in 1997 to a high of 11,664 in 2007 ( USDA

ERS, 2009 )

. It is important to note that the current NOP regulations do not specify an acceptable threshold level for the adventitious presence of GE materials in an organic

- labeled product. The unintentional presence of the products of excluded methods wi ll not affect the status of an organic product or operation when the operation has not used excluded methods and has taken reasonable steps to avoid contact with the products of excluded methods as detailed in their approved organic system plan ( Ronald and Fouche, 2006 ; USDA

- AMS, 2010 ) . However, certain markets or contracts may have defined thresholds ( Non

GMO

- Project, 2010 )

.
4.4 Physical Environment

4.4 .1 Water Resources

No Action A lternative: Water Resources The majority of potato production utilizes irrigation as a water source. As discussed in Section 2.3.1, agricultural production can be detrimental to water quality by adding sediments from erosion via surface water, and nutrient loading from fertilizers in to groundwater.

If APHIS chooses the No Action alternative , water usage for irrigation would be expected to continue. Supplemental irrigation may increase in some areas where potatoes have traditionally been grown without irrigation . P otential for water quality impacts will continue.

Preferred A lternative: Water Resources
No changes to agronomic practices which might affect water resources will be necessary to grow Simplot InnateTM potatoes ( Simplot, 2013b )

. Simplot’s studies demonstrate no differences in morphological characteristics and agronomi c requirements between Simplot InnateTM p otato and other potato varieties ( Simplot, 2013b )

. Again, as with the No Action Alternative, supplemental irrigation may increase in some areas where potatoes have traditionally been grown without irrigation, and potential for water quality impacts will continu e

. A determination o f nonregulated status of Simplot InnateTM potatoes is not expected to change the management practices currently employed for potato cultivation. Water quality impacts are ex pected to be the same under the Preferred Alternative as under the No Action Altern ative.

584.4 .2 Soil Quality

No Action A lternative: Soil Quality Increased erosion potential of soil for potato production may result from fairly high tillage requirements, and the small amount of post

- crop plant material left in the soil. Cover crops are often planted to help mitigate this potential.
Land management practices for potato production can affect soil quality. While practices such as tillage, fertilization, the use of pesticides and other management tools can improve soil health, they can also cause substantial damage if not properly used. Several concerns relating to agricultural practices include increased erosion, soil compaction, degradation of soil structure, nutrient loss, increased salinity, change in pH, and reduced biological activity ( USDA

- NRCS, 2001 ) . Methods to improve soil quality include careful management of fertilizers and pesticides; use of cover crops to increase plant diversity and limit the time soil is exposed to wind and rain; and, increased landscape diversity with buffer strips, contour strips, wind breaks, crop rotations, and varying tillage practices ( USDA

- NRCS, 2006 ) . Living cover also protects against erosion, provides habitat and substrate for soil organisms, and increases soil organic residue inputs ( Doran et al. , 1996 )

. If APHIS chooses the No Action alternative, impacts on soil quality are expected to continue.

Preferred A l ternative: Soil Quality A determination of nonregulated status for Simplot InnateTM p otato is not expected to change the management practices currently employed for potato production. If APHIS chooses the Preferred Alternative, potential impacts on soil quality are expected to be similar to those under the No Action Alternative. Bruinsma ( 2003 ) found no differences in soil attributable t o a GE potato cultivar (not this trait). S implot’s studies demonstrate that agronomic characteristics and cultivation practices required for Simplot InnateTM p otato production are indistinguishable from practices used to grow other potato varieties ( Simplot, 2013b ) . Except for the incorporated traits, the ten events are substantially equivalent to their conventional counterparts, thus no changes in plant/ soil interaction are expected.

I f APHIS chooses the preferred alternative, agricultural impacts on soil quality are expected to remain the same as they would if the No Action alternative is chosen.

4.4 .3 Air Quality

No Action A lternative: Air Quality

If APHIS chooses the No Action alternative , emissions associated with vehicles, fugitive dust particles and pestic ides are expected to continue.

Preferred A lternative: Air Quality

59As discussed in Section 2. 2 .3 Air Quality , emissions associated with crop production include vehicular emissions from the use of farm equipment, fugitive dust particles and releases of pesticides. Fugitive dust can arise from fields and unpaved roadways and can be generated by disturbance of bare soil through vehicle traffic, harvesting operations or wind. These impacts are highl y variable across potato growing regions and over time, depending on such factors as vehicle type, crop type, utilization of pesticides, method of application, so il type and weather conditions.
Simplot’s analyses presented in its petition ( Simplot, 2013b ) demonstrate that no changes to agronomic practices will be required to grow Simplot InnateTM p otato. As discussed in Section 2.3.3, agronomic practices that could affect air quality, such as soil preparation, cultivation, pesticide application and harvesting, were ba sed on practices appropriate for each s ite, and were the same for the events and the controls. The results indicated that no changes from the site

- specific practices used for conventional varieties would be needed fo r production of the ten events.

Therefo re, if APHIS chooses the preferred alternative , impacts to air quality resulting from this action are expected to be the same as if the No Action alternative had been chosen.

4.4 .4 Climate Change

No Action Alternative : Climate Change

If APHIS selects the N o Action Alternative, impacts to climate change are expected to continue.

Preferred A lternative : Climate Change

T he range and area of U.S. potato production is not likely to change under the Preferred Alternative. As described in the Simplot petition ( Simplot, 2013b ) and APHIS PPRA ( USDA

- APHIS, 2013a ) , Simplot InnateTM potatoes use identical management strategies to those for conventional potato production. Therefore, no changes are expected in agricultural activities that might affect climate change, such as machine usage and fertilizer application. Collectively, because the range, area, and agronomic practices of potatoes are unlikely to change following a determination of nonregulated status of Simplot InnateTM p otato , the agricultural impacts of potato production on clim ate change are also unlikely to change under the Preferred Alternative.

4.5 . Biological Resources

4.5 .1 Animal Communities

No Action Alternative: Animal Communities

If APHIS chooses the No Action A lternative , animal communities living both within and outside of potato fields are expected to continue to experience impacts similar to the current impacts of agriculture.

60Animals living in or near agricultural fields a re the most likely to be affected by crop production, including aquatic communities, whic h may be affected by sedimentation and turbidity from erosion, or by pesticide runoff.

Preferred Alternative: Animal Communities

N o changes in land use are expected if APHIS chooses the preferred a lternative. In addition, the evaluation presented in the petition ( Simplot, 2013b ) demonstrates that changes in agronomic practices, including practices related to pesticide use and erosion mitigation , are not required for production of Simplot InnateTM p otato . In addition, there are a large number of insects that feed on potato leaves a nd other insects that feed on those pests. Many of these insects, including the Colorado potato beetle, potato aphid, European corn borer, potato leafhopper and potato psyllid are considered pests. The events have not been modified to exhibit any pesticida l activities and do not contain pesticide

- expressing genes. No differences were observed for insects or other animals interacting within the potato ecosystem during the field trials, leading to the conclusion that the Simplot InnateTM potatoes would have t he same impact on other organisms as conventional potatoes ( Simplot, 2013b )

. APHIS reviewed Simplot’s data on field trials ( USDA

- APHIS, 2013a ) and impacts by insects, and concluded that Simplot InnateTM p otato would suffer no greater insect pressure than conventional potatoes ( USDA

- APHIS, 2013a )

. For example, no increase in aphid infestation or damage was reported in t he field observations for all ten Simplot InnateTM p otato events ( Simplot, 2013b ) . Similarly, although aphids are vectors for viruses such as potato virus Y ( USDA

- APHIS, 2013b ) , no increase in viral disease was reported in field observations for seven of the events ( Simplot, 2013b )

. In addition, since potatoes are propagated vegetati vely from seed potato tuber pieces, pollination by bumblebees is not important to potato tuber production. Simplot InnateTM p otato has been genetically engineered to low acrylamide potential and reduced black spot bruise

. Acrylamide only forms after cookin g potatoes at high heat , so this toxic compound is not expected to be a concern for herbivores. Consumption of PPOs by animals would still occur. Phenols occur in wide distribution of plants ( Felton et al. , 1989 ) , but their biological function of remains unclear ( Bachem et al. , 1994 ; Mayer, 2006 )

. The oxidation products of PPO appear to play a role in ge neral plant defense mechanisms against pathogens and pests

. The relationship between PPO and resistance to herbivores has also been studied. PPO activity increases when potato leaves are wounded and at higher rates in response to regurgitant from the pes t Colorado potato beetle ( Kruzmane et al. , 2002 ) . In other plants, the increase of PPO activity is a direct induced defense against insect pests that decreases nutrient availabil ity ( Baldwin and Preston, 1999 ; Partington et al. , 1999 ) . In addition, PPO in glandular trichomes of wild potatoes (and other plants) is involved in resistance to insects ( Plaisted, 1980 ; Steffens, 1994 ) . However, the trichomes of cultivated potatoes contain low amounts of PPO which is not thought to be involved resistance to pests ( Friedman, 1997 )

. Phylogenetic surveys of PPO in land plants shows that the gene family has undergone evolutionary expansion in some plant families, but is reduced or absent in others, which suggests that

61PPO function is probably diverse ( Tran et al. , 2012 ) . PPO has also been implicated in other functions such as buffering of plastid oxygen levels, wound healing, and chloroplast metabolism ( Steffens, 1994 )

. In potato, PPO is involved in black spot bruise formation, which reduces the quality of harvested tubers ( Bachem et al. , 1994 ; Corsini et al. , 1999 ; Partington et al. , 1999 ) . These dark

- pigmented polyphenols, also referred to as melanins, result in the darkening of potato tissue following mechanical bruising ( Thygesen et al. , 1995 )

. This suggests that Simplot InnateTM p otato is expected to be unchanged relative to PPO gene expression and PPO levels in leaves and therefore unchanged in any potential interactions between potato foliar PPO and foliar pathogens or pests. No consistent differences were observed in foliar pest and pat hogens

on Simplot potatoes compared to their control varieties ( Simplot, 2013b ; USDA

- APHI S, 2013a )

. Simplot did not assess nema tode damage of Simplot InnateTM potato, but Osman et al. ( Osman et al. , 2012 ) suggest that PPO might be involved in resistance to some plant parasitic nematodes, but d o not provide data demonstrating such a role or address the species that affect potatoes. Conversely, lower PPO levels might increase the resistance of Simplot InnateTM p otato to some nematodes. Other researchers found that tubers of potato cultivars resist ant to the potato cyst nematode, G lobodera pallida , have lower levels of phenols and discolored less than tubers of susceptible cultivars ( Mondy et al. , 1985 ) . They suggest that PPO

- mediated tanning of nematode cysts enables eggs to remain viable in soil for a longer time. Lyon ( Lyon, 1989 ) reviewed the biochemical basis for resis tance of potato to bacterial soft rot caused by Erwinia spp. Because it is the dominant monophenol, chlorogenic acid has been a focus in many of these studies. Chlorogenic acid did not inhibit the in vitro growth of Erwinia spp. or P. infestans (the caus al agent of late blight), and there remains no proof that phenols are important in the interaction between potato and Erwinia spp. ( Lyon, 1989 )

. Kroner et al. ( Kroner and Marnet, 2012 ) evaluated the role of specific ph enolics in quantitative resistance to the elicitors of two pathogens, P. infestans , the causal agent of late blight, and Pectobacterium atroseptiucm (synonym: E. carotovora subsp. atroseptica ), the causal agent of bacterial soft rot. Increasing concentrat ions of total phenolics tended toward a positive correlation with quantity of symptoms due to the late blight pathogen, but were negatively correlated with increased tuber rot severity due to the soft rot pathogen. Because chlorogenic acid accumulates in response to soft rot elicitors, these authors suggest that chlorogenic acid could be used as a marker for resistance to soft rot ( Kroner and Marnet, 2012 ) . Since chlorogenic acid is a PPO substrate, silencing of PPO would not be expected to re duce the level of chlo rogenic acid in potato tubers.
Although animals would not be exposed to acrylamide, Simplot InnateTM p otato tubers contain increased levels of glutamine ( Simplot, 2013b ) because the enzyme asparagine synthetase also functions to deaminate glutamine to glutamate ( USDA

- APHIS, 2013a ) . In all of the field trials tested by Simplot, these differences were within the 99% tolerance intervals generated from nine non

- GE commercial control potato varieties grown concurrently at the same field sites ( USDA

- APHIS, 2013a )

. Souba ( 1991 ) noted that in mammalian cells, glutamine acts as a nitrogen donor for the biosynthesis of important compounds such as nucleotides and amino acid

. Consumption of increased glutamin e has been tested

62by some researchers. For example, Wang et al. ( 2008 ) reported that intestinal dysfunction and atrophy were prevented when piglets’ diets were supplemented with glutamine. Similarly, Boukhettala et al. ( 2010 ) showed that adding glutamine to rat diets reduced injury to the intestinal mucosa following a course of chemotherapy , and Klimberg et al. ( 1990 ) demonstrated that added glutamine protects rat intestinal mucosa following radiation therapy.
There were no significant d ifferences between any of the ten events and their respective control varieties for mean glycoalkaloid toxin content ( S implot, 2013b )

.
RNAi

- mediated gene suppression generally requires sequence homology of at least 90% between the silencing construct and the target sequence to be successful and even higher degrees of homology over 21

- 23 nucleotide stretches ( Sharp, 2001 )

. It is not likely that the genetic construct componen ts responsible for gene silencing in the Simplot events would contribute to silencing of genes in other non

target organisms through direct consumption of pollen by pollinators or through secondary exposure of beneficial predator or parasitic arthropods or other potential biological control agents for potato pests ( Sharp, 2001 ; Lundgren and Duan, 2013 ) since sequences from arthropods, bacteria, fungi and viruses are expected to be highly divergent from the sequences used to silence genes in the Simplot potatoes. Furthermore, indirect exposure scenarios are unlikely to lead to impacts to non

- target predators and parasitic arthropods since 1) they may not receive effective doses, 2) intracellular amplification of siRNA, the active gene silencing component derived from dsRNA, is not widely found in insects, 3) environmental and physiological conditions in the gut may destroy the RNA, 4) and they may not have the appropriate receptors to allow transmembrane movement of dsRNA or the appropriate enzyme to direct RNAi (e.g. Dicer, Argonaute, RdRP, RNA and DNA helicases) ( Lundgren and Duan, 2013 )

. The introduced genes did not significantly alter the observed insect pest infestation and disease occurrence or resulting damage in Simplot InnateTM p otato relative to the control line under the ty pical recommended pest management conditions. Therefore, APHIS concludes that based on the compositional similarity of Simplot potato tubers to the parent varieties, the observed interactions of Simplot potatoes with insects and pathogens, and the unlikely impacts of nontarget effects due to RNAi, that the consumption of or indirect exposure to Simplot tubers or other plant parts is unlikely to have adverse impacts on animals in or near potato fields

. Consumption of Simplot InnateTM p otato is unlikely to substantially affect non

- target organisms, such as mammals, birds, or insects. Simplot data demonstrates that the composition of Simplot InnateTM p otato does not substantially differ from conventional potato varieties ( Simplot, 2013b )

. Simplot indicated that they have submitted a safety and nutritional as sessment of food and feed derived from Simplot InnateTM p otato to the FDA on February 12, 2013 ( Simplot, 2013b ) . FDA is presently evaluating the submission. There is no evidence that animal exposure to Simplot InnateTM p otato would have any effect or be any less attractive as food, refuge, cover and nesting sit es as non
- GE varieties of potatoes

. In general, migratory birds are not expected to feed on potato plants because of their glycoalkaloid content, while cover and nesting sites also appear comparable to conventional varieties because the GE plants are agronomically si milar

. 63The modifications did not alter the quality of potato as food other than lower levels of acrylamide after cooking, and lower black spot bruise. There would be no effect from consumption of InnateTM p otato plant parts because there is nothing different between the plant parts of these varieties and plant parts of other potato varieties already in production.
Considering all that is known about Simplot InnateTM potato lines and their production, there is nothing to indicate that migratory birds w ould interact or be affected any differently than they would with other potato varieties currently grown.

4.5 .2 Plant Communities

No Action Alternative: Plant Communities If APHIS selects the No Action Alternative, impacts to plant communities as a result of potato production are expected to continue.

Preferred Alternative: Plant Communities Simplot has presented the results of field trials which demonstrate that Simplot I nnateTM potatoes do not require any changes to agronomic inputs when compared with conventional potatoes ( Simplot, 2013b )

. There would be no change in herbicide use or patterns.
The silencing of acrylamide potential leads to somewhat heightened levels of glutamine in Simplot InnateTM potato , but levels are within acceptabl e limits ( OECD, 1997 )

. In the very unlikely event of hybridization of Simplot InnateTM potato, resu lting progeny may have altered levels of asparagine. Plants use asparagine as a nitrogen source when they are unable to store nitrogen in the form of protein , and can accumulate to very high c oncentrations ( Halford et al. , 2012b )

. As discussed in Section 4.5 .1, Animal Communities , consumption of Simplot InnateTM p otato is not expected t o change herbivore

- plant interaction s. Under the Preferred Alternative, potential impacts to plant communities are not anticipated to be different compared to the No Action Alternative.

Land use and agricultural production of potatoes under the Preferred Alternative is likely to continue as currently practiced. Consequently, any impact to plant communities as a result of potato production practices under the Preferred Alternative is the same as the No Action Alternative.

4.5 .3 Gene Fl ow and Weediness

No Action Alternative: Gene Flow and Weediness If APHIS selects the No Action Alternative, there would continue to be little problem with gene flow or weediness for potato.

64Preferred Alternative: Gene Flow and Weediness If APHIS selects th e Preferred Alternative, no changes in agronomic practices are expected to occur ( USDA

- APHIS, 2013a ) which might make potato, including Simplot InnateTM p otato more susceptible to gene flow or weediness.

4.5 .4 Mic roorganisms
No Action Alternative: Microorganisms If APHIS chooses the No Action A lternative , potato crop interactions with microorganisms are e xpected to remain the same over time

. Preferred Alternative: Microorganisms
Under the Preferred Alternative, the impacts to microorganisms are expected to be the same as if the No Action Alternative is chosen. T he evaluation presented in the petition ( Simplot, 2013b ) demonstrates that changes in agronomic practices, including practices related to soil preparation (which may impact soil organic m aterial and pH) and to pesticide application (which may directly impact microorganisms), would not be required for production of the ten Simplot Innate TM p otato events. T he ten Simplot Innate TM p otato events are substantially similar to conventional potatoes with respect to disease susceptibility ( USDA

- APHIS, 2013a )

. Tuber browning can be a plant response to infection by microbial pathogens, so modified potato tubers may not to exhibit the same degree of sym ptoms as conventional varieties. Plant infection can also induce the production of other compounds that produce browning (e.g. phenolics) so a complete absence of symptoms in GE varieties is unlikely ( USDA

- APHIS, 2 013a ) . If there are no disease symptoms, or if symptoms are reduced below action thresholds, then it is unlikely a farmer would increase pesticide

use. A safety assessment of mice fed a diet of GE non
- browning potatoes showed no adverse effects in mouse gut microbiota ( Llorente et al. , 2011 )

.
4. 4.5 Biodiversity

No Action Alternative: B iodiversity

If APHIS chooses the No Action alternative , increases in potato productivity are expected to continue to offset increased demand, resulting in a fairly constant acreage devoted to potato production in the country. This will allow for continue d trends of biodiversity occurring outside the borders of agricultural fields even though b iodiversity. Biodiversity is expected to continue to be fairly low within agricultural fields.

65Preferred Alternative: Biodiversity Under the Preferred Alternative, biodiversity is unlikely to be substantially changed in comparison to the No Action Alternative. First, t he evaluation presented in the petition ( Simplot, 2013b ) demonstrates that changes in agronomic practices would not be required to incorporate production of the ten events. This

means cultivation, management, and land

- use decisions related to Simplot InnateTM potatoes are not different from conventional potato cultivars . Agronomic practices such as irrigation, pesticide application, fertilizer applications , and agriculture equipment would be unchanged by the addition o f these two varieties

. Thirdly, flora and fauna that typically inhabit potato fields will continue to be affected by currently used management plans and production systems. The consequences of current agronomic practices associated with potato production on the biodiversity of plant and animal communities are unlikely to be altered.
Consequently, any impact to biodiversity as a result of potato production practices under the Preferred Alternative is likely to be identical to the No Action Alternative.

4.6 Human and Animal Health

4. 6

. 1 Human Health

Potato is primarily grown for human consumption. U.S. per capita potato consumption is approximately 112 pounds per year. Of this, approximately 65 pounds is used for frozen fries or chips. Per capita consumpti on data are shown in Table 6. As discussed in Section 2. 4

. 1 , Human Health, potential toxins in potatoes are acrylamide , which forms subsequent to high

- temperature cooking, and glycoalkaloids. P atatin is allergen ic to a very small percent age of children.

No Action Alternative: Human Health Under th e No Action alternative, consumption of potatoes would be expected to continue at the same rate as currently . Consumers will continue to be exposed to similar levels of acrylamide in cooked potatoes if other me thods are not employed to reduce levels. Glycoalkaloids would be expected to remain at sufficiently low levels such that health impacts would not occur. Patatin would remain a

co ncern for allergic individuals

. Preferred Alternative: Human Health

If APHIS chooses the Preferred Alternative , and Simplot InnateTM p otato is widely adopted , acrylamide content in cooked potatoes c ould be significantly reduced, leading to potential health benefits for

consume r s. Compared with conventional potatoes, Simplot Innate TM p otato contains, on average, 58 to 72 % less acrylamide when cooked ( NTP, 2011 ; Simplot, 2013b )

. As discussed in Section 2. 4

. 1 , Human Health, the State of California listed acrylamide as a potential carcinogen under Proposition 65 in 1990 and established a No Significant Risk Level (NSRL) of 0.2 μg/day ( CEPA

- OEHHA, 2005 ) , which was later revised to 1.0 μg/day ( CEPA

- OEHHA, 2005 ) . The FDA is considering issuing guidance concerning safety of acrylamide ( FDA, 2009 ) , and in 2013, published ( FDA, 2013b ) recommendations that health

- conscious

66consumers may want to avoid the consumption of fried potato products

. Especially since American consumpt ion of French fries is high ( USDA

- NASS, 2012c ) , these developments regarding acrylamide safety may lead to processor preference for Simplot InnateTM p otato in French fries and other frozen potato products. In the absence of these alternative varieties, food producers voluntarily alter their production practices to reduce acrylamide in their products. Deployment of these genes would allow them an alternative way to produce reduced acrylamide products.

T he data presented in the petition shows that the Simplot InnateTM p otato events are at least as safe and nutritious for food as the untransformed controls ( Simplot, 2013b )

. The compositional analyses of the ten events are summarized in the petition, with detailed results in Appendix 9 ( Simplot, 2013b ) . The compositional assessments determined the amounts of 1) moisture, protein, total fat, ash, crude fiber, carbohydrate and calories; 2) vitamins B6, B3 and C; 3) minerals copper, magnesium and potassium; 4) glycoalkaloids; 5) free amino acids; and 6) total amino acids for tubers collected from events grown in 2009, 2010, and 2011 in potato

- growing areas of the United States. Observed changes in ASN and reducing su gars accomplished through transformation of various potato varieties resulted in lower acrylamide levels in French fries and potato chips. These modifications did not alter the quality of potato as food because all results fell within normal ranges for pot ato. In addition, the research confirmed that glycoalkaloid levels were unchanged compared with the control varieties.
Based on the results in results in the petitioner’s Appendix 9 (Simplot, 2013a), t he potato events described in this petition do not ap pear to be compositionally different in compar ison to untransformed controls, except for the intended traits. Therefore, issues with allergies are not expected to differ from those in the currently affected environment or under the No Action alternative.
The National Academy of Sciences (NAS) has ranked methods of genetic modification according to the relative likelihood of unintended effects, such as the increase in a plant’s production of certain allergens. The NAS considered methods that involve reco mbinant DNA via Agrobacterium transfer of genes from closely related species (the Simplot InnateTM method used to produce these ten events is one such method that does not involve the transfer of genes) to be among the methods least likely to have unintende d effects

– less likely than conventional pollen

- based crossing of closely related species

– and far less likely than methods such as ionizing radiation and chemical mutagenesis, which are not subject to regulation and are not excluded methods under the NO P ( Sciences, 2004 )

.
4. 6

. 2 Worker Safety

No Action Alternative: Worker Safety

If APHIS were to choose the No Action alternative , farm and food production workers would continue to be exposed to the same types and amounts of hazards as they currently experience in potato production and food processin g

. Preferred Alternative: Worker Safety

67Under the Preferred Alternative, t here will be no changes in agronomic or food production practices in order to produce food and feed from Simplot InnateTM p otato

. C onsequently , impacts to worker health resulting from approval of the petition are expected to be the same as if the No Action A lternative is chosen.
Simplot demonstrates in its petition that the agronomic inputs required to cultivate Simplot Innate TM p otato are functio nally equivalent to those required for conventional potatoes ( Simplot , 2013b )

. Current health and safety protocols are not likely to require changes to accommodate the production or handling of Simplot InnateTM potatoes because the characteristics of the potatoes are not altered. Normal harvesting, transport, and storag e conditions designed to minimize the accumulation of gl ycoalkaloids and acrylamide do not need to be altered to accommodate these potato varieties.

4. 6

. 3 Animal Feed

No Action Alternative: Animal Feed

As discussed in Section 2. 4.3 , Animal Feed , a small portion of the potato crop and waste from processing are sold as livestock feed. If APHIS selects the No Action A lternative , a small percent of the potato crop would continue to be used for livestock feed.

Preferred Alternative: Animal Feed

The compositional analyses of the ten Simplot Innate TM events are summarized in Section 8 of the petition, with detailed results in Appendix 9 ( Simplot, 2013b )

. Additionally, the nutritional and compositional differences between Simplot Innate TM potatoes and conventional potatoes were evaluated in the USDA

- APHIS PPRA (2013a) and found to be similar

. The composition of Simplot Innate TM potatoes are within the ranges of normal variation with conventional potatoes with respect to protein and carbohydrate content available in feed ( USDA

- APHIS, 2013a )

. As a result, incorporation of Simplot Innate TM potatoes into animal feed is unlikely to affect palatability of the feed

. The composition of Simplot Innate TM potatoes are within the ranges of normal variation with conventional potato es with respect to protein and carbohydrate content available in feed ( USDA

- APHIS, 2013a )

. In conclusion, the data presented in the petition shows that potatoes from the events are as safe and nutritious for feed as the untransformed controls, and if APHIS were to choose the Preferred A lternative , the use of potatoes as livestock feed would be no different than if the N o Action A lternative was chosen.

684. 7 Socioeconomic Impacts

4. 7 .1 Domestic Economic Environment

No Action Alternative: Domestic Economic Environment The domestic economic environment is discussed in Section 2. 5.1 , Socioeconomic: Domestic Economic Environment , and potato utilization in t he country is summarized in Table 8 . Potatoes are grown on appro ximately 1.1 million acres in the United States , with an annual value of approximately $3.5 billion. Major products include fresh potatoes, frozen fries and chips. Organic potatoes account for less than one percent of the market.

If APHIS chooses the No Action alternative , domestic potato production, including organic production, is expected to continue at rates similar to the present. The USDA projects an approximate 4.6 % increase in production between 2012 and 2021 ( USDA, 2012 )

.
Preferred Alternative: Domestic Economic Environment If APHIS chooses the P referred A lternative, the ten Simplot Innate TM p otato will become available for commercial production. Because of the reduced potentia l for black spot bruise of Simplot InnateTM p otato , wastage is expected to decrease . This will lead to greater efficiency in processing, and an improved revenue s tream for product producers

. Overall, if APHIS chooses the Preferred Alternative, the introduction of Simplot InnateTM potato are likely to have positive economic impacts on potato growers that choose to grow Simplot InnateTM potato.
Potatoes with low acrylamide potential and reduced black spot bruise are expected to have higher market value for the same inputs, representing potential increased revenue for growers and processors, and an overall increase in the value of potato production. The initial crop introduction will build up slo wly as seed becomes available and will be controlled within existing processing channels to ensure that potatoes enter only the intended markets. This will provide a period of time to assess consumer acceptance and to address grower and industry concerns. A limited introduction that is initially in a vertically integrated supply chain will be well controlled by grower and processor agreements. In this situation, conventional products will be considered “identity preserved” with respect to the well

control led stewardship of the potato event(s) and its products. As adoption of the potato events increases, programs for identity preservation will be implemented as needed. It is expected that development and implementation of identity preservation systems wil l add some cost to the supply chain; the total costs will depend upon the type and extent of market penetration ( Simplot, 2013b )

. Organic potato growers are not anticipated to incur additional operating costs to as a result of the Preferred Alternative. See Section 4. 3.4 for further discussion.

694. 7 .2 Trade Economic Env ironment

As discussed in Section 2. 5.2 , Socioeconomic: Trade Economic Environment , the United States exports more than $1 billion in potato products annually, primarily consisting of frozen fries and other processed potatoes. Demand from Canada, Mexico , and Asia is driving growth in exports. Japan is the largest market for U.S. exports of frozen potatoes, while Canada is the largest U.S. export market for chips and fresh potatoes. The United States also has substantial imports of potatoes and potato pr oducts from Canada and Mexico ( USDA

- ERS, 2012a )

.
No Action Alternative: Trade Economic Environ ment If APHIS chooses the No Action alternative , U.S. potato exports are expected to continue as affected by market forces

.

Preferred Alternative: Trade Economic Environment

If APHIS chooses the preferred alternative , U.S. potato exports are expected to continue as affected by market forces . Approval for the events will be sought in Canada, Japan and Mexico ( Simplot, 2013b ) prior to commercial pr oduction beginning in the U.S.
Previous recalls of potato products that were shipped to Japan and then found to contain genetically modified material were related to unapproved events; Japan has zero tolerance for unapproved events ( Reuters, 2001 ) . To assist in the prevention of trade disruptions, as has been experienced with other potato events, international approvals will be pursued from key trading partner countries prior to beginn ing commercial production in the U nited States. These approvals should ensure continued trade with key export markets. Simplot intends to follow the recommended stewardship policy statement released by the Biotechnology Industry Organization in May 2007:
To help ensure the continued adoption of agricultural biotechnology globally and to continue to have products of agricultural biotechnology bring value to the marketplace, BIO’s Food and Agriculture Section supports actions that facilitate the flow of go ods in commerce and minimize trade disruptions. BIO’s Food and Agriculture Section believes that henceforth individual member companies should, prior to commercialization meet applicable regulatory requirements in key countries identified in a market and t rade assessment that have functioning regulatory systems and are likely to import the new biotechnology

- derived plant products.
The voluntary guideline was adopted because, according to BIO “asynchronous authorizations combined with importing countries mai ntaining ‘zero tolerance’ for recombinant

- DNA products not yet authorized results in the potential for major trade disruptions. The potential occurrences of trade disruptions will only increase given the substantial amount of research that will bring many new products and combinations of products to market.”

70In comparison to some biotech crops, the Simplot Innate TM p otato is expected to be viewed more favorably by regulatory organizations due to the lack of pesticidal traits and marker

- free transformation methods . For these reasons, it is anticipated to pose fewer implications for export markets.

If APHIS chooses the preferred alternative , as with the domestic economic environment, the introduction of these potato events may have positive economic impact s on export markets, recognizing that some additional costs could be incurred.

715 CUMULATIVE IMPACTS
A cumulative impact may be an effect on the environment which results from the incremental impact of the proposed action when added to other past, present, and reasonably foreseeable future actions. For example, the potential effects associated with a determination of nonregulated status for a GE crop in combination with the future production of crop seeds with multiple deregulated traits (i.e., “stacked” t raits), including drought tolerance, herbicide tolerance, and pest resistance, would be considered a cumulative impact.
Regulations promulgated by the Council on Environmental Quality (CEQ) under the National Environmental Policy Act (NEPA) define cumulat ive impact as “the impact on the environment which results from the incremental impact of the action when added to other past, present and reasonably foreseeable future actions” (40 CFR 1508.7). For example, the potential effects associated with a determi nation of nonregulated status of a GE crop in combination with the future production of crop plants with multiple traits that are no longer subject to the regulatory requirements of 7 CFR Part 340 or the plant pest provisions of the Plant Protection Act, i ncluding disease tolerance, nitrogen utilization, and herbicide tolerance, would be considered a cumulative impact.
5.1 Assumptions Used for Cumulative Impacts Analysis

Cumulative effects are qualitatively analyzed for each environmental issue assessed in Section 4, Environmental Consequences by focusing on the Preferred Alternative in consideration of related activities including past, present and reasonably foreseeable future actions including the production of potato progeny . In this analysis, if there are no direct or indirect impacts identified by a resource area, then APHIS assumes there can be no cumulative impacts in that area

. APHIS considered the potential for Simplot InnateTM p otato to extend the range of potato production and affect the conversi on of land to agricultural purposes. Simplot’s studies demonstrate that agronomic characteristics and cultivation practices required to produce Simplot InnateTM p otato are indistinguishable from practices used to grow conventional potatoes ( Simplot, 2013b ; USDA

- APHIS, 2013a ) . This implies its cultural requirements would neither differ from other potatoes nor change the areas where potatoes are currently grown. If the petition is approved, Simplot InnateTM p otato could replace other commercially available potato cultivars, without requiring production o n new, previously

non
- cropped land. L a nd use changes associated with approving the petition do not appear to be any different than those associated with conventional potato production. APHIS focused the analysis of cumulative impacts on the areas in the U.S. that currently produce potatoes.

P otential reasonably foreseeable cumulative effects are analyzed under the assumption that some growers have used commonly accepted best management practices (BMPs) in the past , and would continue to use these practices when reasonable under the circumstanc es for their chosen system and cultivars during potato production. APHIS recognizes, however, that not all growers choose to use the

same BMPs.

725.2 Past and Present and Reasonably Foreseeable Actions
The Preferred Alternative is not expected to directly cause a measurable change in agricultural acreage or area devoted to potato production in the U nited States

. The analysis showed Simplot InnateTM p otato is another potato cultivar that is agronomically and compositionally similar to other commercially avai lable potato cultivars, so it is expected that Simplot InnateTM p otato would replace other similar cultivars without expanding the acreage of area devoted to potato production. There is no reason to anticipate changes to the availability of non

- GE potato cultivars on the market based on the entry of this variety into the market.
Approving the petition for a determi nation of nonregulated status for Simplot InnateTM p otato is not expected to change current potato production practices. Studies conducted by Simplot demonstrate th e agronomic characteristics and cultivation practices of Simplot InnateTM p otato are indistinguishable from practices used to grow other potato cultivars ( Simplot, 2013b ; USDA

- APHIS, 2013a )

. Consequently, progeny bearing these genes also appear unlikely to requi re different practices.

O rganic growers use common practices to maintain the organic status in their potato production, including employing adequate isolation distances between the organic potato field and the fields of neighbors to minimize the chance that pollen will be carried among fields. Given the importance of maintaining varietal traits and consumer recognition and preference for specific potato cultivars, the separation of production and processing of potatoes by cultivars is routinely utilized by growers, packers and retailers in the United States market to satisfy consumer preference and demand. Availability of

a nother potato cultivar, such as Simplot InnateTM p otato under the Preferred Alternative, is not expected to impact the organic production of potatoes any differently than other potato cultivars currently being grown. Progeny bearing these genes may become d eliberately added to specific potato cultivars based on market demand, and the choice to produce those modified varieties remains with each individual farmer.

Based on the info rmation described in Section 4. 7 .1 , Domestic Trade Environment, APHIS concludes that a determination of nonregulated status of Simplot InnateTM p otato will have no foreseeable adverse cumulative effects on domestic commerce. Simplot InnateTM p otato has the potential to improve potato processing capabilities a nd also improve the economic s of potato processing and consumer nutrition. There may also be a reduction in cost of processing associated with a reduction in potato browning and in providing alternatives to conventional technologies to prevent browning. Progeny bearing these genes a re anticipated to have the same potential for benefits. Based on these factors, no net negative cumulative impacts on domestic economics are identified associated with the production of Simplot InnateTM p otato

. Approving the petition for a determination of nonregulated status to Simplot InnateTM p otato would have the same impacts to water, soil, air quality, and climate change as that of potato cultivars currently available. Agronomic practices that have the poten tial to impact soil, water and air quality, and climate change would not change because Simplot InnateTM p otato is agronomically similar to other potato
73cultivars. Because of its similarity to other potato cultivars, adoption of Simplot InnateTM p otato is

ex pected to replace other similar cultivars without impact ing water, soil, air quality, and climate change differently from other potato varieties

. Cumulative impacts due to climate change are anticipated to be the same for Simplot InnateTM events and convent ional potatoes becau se the ir agronomic characteristics remain similar. Additionally, potato production in the United States occurs on less than one percent of the acreage as compared to the acreage occupied by corn and soybeans (USDA NASS, 2012b) so the

m agnitude of any climate change due to potato production changes appears unlikely to be detectable

. Cumulative i mpacts of the Preferred Alternative to microorganisms and biodiversity are not expected to be significantly different tha n under the No A ction Alternative because Simplot InnateTM p otato is agronomically and compositionally similar to other potato cultivars

. Cumulative impacts to plant communities resulting from gene flow or weediness potential would be the same for Simplot InnateTM p otato events and conventional potatoes based on m ultiple years of field data , compositional analysis , and a lack of changes in agronomic inputs ( including pesticides and herbicides ) . Gene flow from potatoes , whether biotech or conventional , is unlikely due to the cropp ing practices of rotation and the clonal propagation of potato varieties in U.S. agriculture. Consequently, this variety does not present a safety risk, or pose an increased weediness risk in relation to other currently available potatoes based on the info rmation summarized in the PPRA ( USDA

- APHIS, 2013a )

. Cumulative impacts to animal communities would be the same for Simplot InnateTM p otato events and conventional potatoes. Three years of field data as well as compositional analysis and molecular stability show that Simplot InnateTM p otato events are equivalent to conventional potatoes ( Simplot, 2013b )

. Even in cases where asparagine was lower (for reducing acrylamide), the levels were still within the combined literature ranges. In addition, no changes were observed in land us e or agronomic inputs including pesticides. Animals consuming Simplot InnateTM p otato may be exposed to increased levels of glutamine, but research on dietary supplementation with glutamine has not had any negative animal health effects. In the future, mult iple potato varieties carrying these genes may lead to an increased risk of exposure to increased levels of glutamine, but consumers are more likely to substitute varieties rather than increasing their potato consumption.
In general, c umulative effects on human consumer health are expected to be the same for Simplot InnateTM p otato events and conventional potatoes . There is one major exception: the Simplot InnateTM p otato contains significantly less acrylamide

- forming potential than conv entional potatoes. Reduced levels of acrylamide in cooked potatoes are associated with human health benefits in consumers. Reduced potential to form acrylamide should result in significant human health benefits, particularly for those with a diet high in p otato products produced by cooking at high temperatures

. Compared with the conventional varieties, Simplot InnateTM p otato contained on average 58 to 72 percent less acrylamide ( Simplot, 2013b ) . Adoption of these potatoes could result in a significant reduction in dietary intake of acrylamide and decrease exposure to th is naturally occurring substance found to cause cancer in laboratory animals ( NTP, 2011 )

.

74In addition, total protein and glycoalkaloid levels in Simplot InnateTM p otato were unchanged compared with the control varieties ( Simplot, 2013b )

. Although patatin was not measured during the studies ( Simplot, 2013b ) , any potential exposure to patatin is not expected to be different under the Pr eferred Alternative than under the No Action Alternative. Some allergies have been detected in children as a result of patatin; however, these allergies are only in children and are uncommon ( De Swert et al. , 2002 ; 2007 ) . Children who are allergic to potatoes would avoid potatoes under the No Action A lternative; therefore, any changes in patatin levels in Simplot InnateTM potato would not impact these children , as they are already avoiding potatoes due to the high proportion of patatin already occurring in conventional potato varieties ( Mignery et al. , 1988 )

. Cumulative impacts to worker safety would be expected to be the same for Simplot InnateTM p otato events and conventional potatoes because the agronomic pract ices are not expected to change

. Livestock consuming raw potatoes are not expected to realize any health benefits from reduced acrylamide

- forming potential in these potatoes. Simplot submitted a safety and nutritional assessment of food and feed derived fr om Simplot InnateTM p otato to the FDA on date February 12, 2013 ( BNF No. 141 )

. The FDA is presently evaluating the submission. There are n o change s in food and feed safety expected to occur under the Preferred Alternative.
Cumulative impacts on the domestic economic environment generally would be similar for Simplot InnateTM p otato events and conventional potatoes, although some economic impact is expected because of the potential health benefits associated with the se new pot atoes. These events grow similarly and have similar biochemical composition to conventional potatoes, however, the low acrylamide, reducing sugars, and black spot bruise traits add value that could increase the price received for these potatoes. Potatoes with low acrylamide potential and reduced black spot bruise are expected to have higher market value for the same inputs, representing potential increased revenue for growers and processors, and an overall increase in the value of potato production. To th e extent that these traits become incorporated into many other existing varieties, this added market value is anticipated to diminish.
Cumulative impacts to the trade economic environment generally would be similar for Simplot InnateTM events and conventio nal potatoe s, unless the potential health benefits become an important factor in international marketing. Increased demand is expected to lead to increased supply of these potatoes, but to the extent that other countries indiscriminately block importation of GE foods, these opportunities may be missed.

Introduction of Simplot InnateTM p otato will require channeling of the new potatoes into the desired markets. The careful supply chain introduction would be similar to all potato variety management systems already in place for product purity. It is expected that development and implement ation of identity preservation systems will add some cost to the supply chain; the total costs will depend upon the type and extent of market penetration ( Simplot, 2013b ) . The Simplot InnateTM p otato could have cumulative economic impacts on the domestic potato market and procedures developed to manage product purity in the supply chain.

75Upon introduction, procedures will be implemented to prevent unintended mixing of Simplot InnateTM with conventional potatoes as part of the stewardship program. In addition, Simplot is seeking international regulatory approvals in areas s uch as Japan and Mexico for import approval. Also, approval in Canada is being sought for import and cultivation. Approval in these key trading countries will minimize market disruption should a low

- level presence of Simplot InnateTM potatoes be found in th e market from accidental mixing. T he Simplot InnateTM potatoes could have cumulative trade economic impacts on the potato export market and procedures developed to manage product purity in the supply chain.
Simplot InnateTM p otato , and the deployment of the genes in this variety, may offer protection against black spot bruise, slight changes in reducing sugars, and reduced acrylamide potential. During processing, potatoes are routinely culled due to black spot bruise when making French fries or potato chips, however, with Simplot I nnateTM p otato, fewer potatoes will be lost to black spot bruise, resulting in less waste. As a result of increased usable yield per pound existing production becomes more efficient, so less acreage can meet the demand for potatoes. Reductions in potato acreage are associated with fewer agricultural inputs and concomitant environmenta l benefits with associated positive environmental impacts related to land use and agricultural inputs. For the purposes of th is cumulative impacts discussion, however, it is conservatively assumed that land use and agronomic inputs would potentially decline or remain the same, and are unlikely to increase

.

766 TH REATENED AND ENDANGE RED SPECIES
The Endangered Species Act (ESA) of 1973, as amended, is one of the most far

- reaching wildlife conservation laws ever enacted by any nation. Congress passed the ESA to prevent extinctions facing many species of fish, wildlife and plants. The purpose of the ESA is to conserve endangered and threatened species and the ecosystems on which they depend as key components of America’s heritage. To implement the ESA, the U.S. Fish & Wildlife Service (USFWS) works in cooperat ion with the National Marine Fisheries Service (NMFS), other Federal, State, and local agencies, Tribes, non

- governmental organizations, and private citizens. Before a plant or animal species can receive the protection provided by the ESA, it must first be added to the Federal list of threatened and endangered wildlife and plants.
A species is added to the list when it is determined by the USFWS/NMFS to be endangered or threatened because of any of the following factors:

• The present or threatened destructio n, modification, or curtailment of its habitat or range;

• Overutilization for commercial, recreational, scientific, or educational purposes;

• Disease or predation;

• The inadequacy of existing regulatory mechanisms; and

• The natural or manmade factors affecting its survival.
Once an animal or plant is added to the list , protective measures apply to the species and its habitat. These measures include protection from adverse effects of f ederal activities.
Section 7 (a)(2) of the ESA requires that federal agenci es, in consultation with USFWS and/or the NMFS, ensure that any action they authorize, fund, or carry out is “not likely to jeopardize the continued existence of a listed species or result in the destruction or adverse modification of designated critical h abitat.” It is the responsibility of the federal agency taking the action to assess the effects of their action and to consult with the USFWS and NMFS if it is determined that the action “may affect” listed species or designated critical habitat. To faci litate their ESA consultation requirements, APHIS met with the USFWS from 1999 to 2003 to discuss factors relevant to APHIS’ regulatory authority and effects analysis for petitions for nonregulated status and developed a process for conducting an effects d etermination consistent with the Plant Protection Act (PPA) of 2000 (Title IV of Public Law 106

- 224). APHIS uses this process to help fulfill its obligations and responsibilities under Section 7 of the ESA for biotechnology regulatory actions.

APHIS me t with USFWS officials on June 15, 2011, to discuss whether APHIS has any obligations under the ESA regarding analyzing the effects of herbicide use associated with all GE crops on TES. As a result

77of these joint discussions, USFWS and APHIS have agreed t hat it is not necessary for APHIS to perform an ESA effects analysis on herbicide use associated with GE crops currently planted because EPA has both regulatory authority over the labeling of pesticides and the necessary technical expertise to assess pesti cide effects on the environment under FIFRA. APHIS has no statutory authority to authorize or regulate the use of pesticides used by potato growers. Under APHIS’ current Part 340 regulations, APHIS only has the authority to regulate the InnateTM p otato or any GE organism as long as APHIS believes they may pose a plant pest risk (7 CFR § 340.1) . APHIS has no regulatory jurisdiction over any other risks associated with GE organisms including risks resulting from the use of herbicides or other pesticides on those organisms.
After completing a plant pest risk analysis, if APHIS determines that seeds, plants, or parts thereof from Simplot InnateTM p otato do not pose a plant pest risk, then these articles would no longer be subject to the plant pest provisions of the PPA or to the regulatory requirements of 7 CFR Part 340, and therefore, APHIS must reach a determination that these articles are no longer regulated. As part of its EA analysis, APHIS is analyzing the potential effects of these potato events on the environment including, as required by the ESA, any potential effects to threatened and endangered species and critical habitat. As part of this process , APHIS thoroughly reviews the GE product information and data related to the organism (generally a pla nt species, but may also be other genetically engineered organisms). For each transgene/transgenic plant, APHIS considers the following:

• A review of the biology and taxonomy of the crop plant and its sexually compatible relatives;

• Characterization of eac h transgene with respect to its structure and function and the nature of the organism from which it was obtained;

• A determination of where the new transgene and its products (if any) are produced in the plant and their quantity;

• A review of the agronomic p erformance of the plant, including disease and pest susceptibilities, weediness potential, and agronomic and environmental impacts;

• Determination of the concentrations of known plant toxicants (if any are known in the plant);

• Analysis to determine if the t ransgenic plant is sexually compatible with any threatened or endangered species (TES) of plants or a host of any TES; and

• Any other information that may inform the potential for an organism to pose a plant pest risk.
In following this review process, APHIS, as described below, has evaluated the potential effects that a determination of nonregulated status of the potato events may have, if any, on federally

- listed TES species and species proposed for listing, as well as designated critical habitat and h abitat proposed for designation.
Based upon the scope of the EA and production areas identified in the Affected Environment section of the EA, APHIS reviewed the USFWS list of TES species (listed and proposed) for each state where potato

78is commercially pr oduced from the USFWS Environmental Conservation Online System (ECOS; as accessed February 19, 2014 at http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrence.jsp ) , ( USDA

- APHIS, 2014c ; 2014a ) . Prior to this review, APHIS considered the potential for Simplot InnateTM p otato to extend the range of potato production and also the potential to extend agricultural production into new natural areas. APHIS has determined that agronomic characteristics and cultivation practices required for Simplot InnateTM p otato are essentially indistinguishable from practices used to grow other potato varieties ( Simplot, 2013b ; USDA

- APHIS, 2013a )

. Simplot InnateTM p otato may be expected to replace other varieties of potato currently cultivate d, and APHIS does not expect the cultivation of Simplot InnateTM p otato to result in new potato acres to be planted in areas that are not already devoted to agriculture. Accordingly, the issues discussed herein focus on the potential environmental conseque nces of the determination of nonregulated status of Simplot InnateTM p otato on TES species in the areas of the US where potatoes are currently grown.
JR Simplot has used a genetic engineering approach to introduce into the background of commercial potato cu ltivars two traits that are of interest to potato consumers, producers and processors: reduced acrylamide potential in certain processed or heated potato products and reduced black spot bruise ( Simplot, 2013b )

. Simplot used the single construct pSIM1278 to transfor m 5 different commercial par ent varieties and created the ten events described in the petition. The objective was to incorporate the same new phenotypes into each of these important varieties, while maintaining all of the desirable characteristics origina lly selected by potato breeders ( Simplot, 2013b ) . Unlike most GE agricultural products that have been commercialized to date, the transformation in this instance does not result in production of proteins. The inserted DNA contains silencing cassettes that, when expressed, generate variably

- sized and unprocessed transcr ipts. These transcripts trigger the degradation of mRNAs that would normally code for an enzyme, like asparagine synthetase. This results in much reduced levels of the targeted “silenced” enzymes ( Simplot, 2013b ) . As described in the petition and PPRA, the potato lines were transformed to silence four different genes in potato: asparagine synthetase

- 1 ( Asn1 ), polyphenol oxidase

- 5 ( Ppo5 ), potato phosphorylase L ( PhL ) and the starch

- associated R1 gene ( R1 ). The suppression of Asn1 results in potatoes with reduced free asparagine, and the suppression of PhL and R1 results in potatoes with a lower content of reducing sugars. Collectively, the silencing of these 3 genes should result in potato tubers with a reduced acrylamide potential. The suppression of Ppo5 confers the Simplot InnateTM p otato with a non

- browning phenotype resulting in tubers with reduced black spot bruising ( Simpl ot, 2013b ) , ( USDA

- APHIS, 2013a )

. For its analysis on TES plants and critical habitat, APHIS focused on the agronomic differences between Simplot InnateTM p otato and potato varieties currently grown; the potent ial for increased weediness; and the potential for gene movement to native plants, listed species, and species proposed for listing.
For its analysis of effects on TES animals, APHIS focused on the implications of exposure to Simplot InnateTM p otato, and the potential for an effect resulting from the gene silencing activity that sets Simplot InnateTM p otato apart from other potato lines currently in production.

796.1 Potential Effects of Simplot InnateTM Potato on TES and Critical Habitat

Threatened and Enda ngered Plant Species and Critical Habitat
The agronomic and morphologic characteristics data provided by JR Simplot were used in the APHIS analysis of the weediness potential for Simplot InnateTM p otato, and further evaluated for the potential to impact TES and critical habitat. Agronomic studies conducted by JR Simplot over several years tested the hypothesis that there would be no change in agronomic practices used to produce Simplot InnateTM p ota to in comparison with conventional potato ( Simplot, 2013b ) . Agronomic evaluations were conducted in geographically distinct sites selected to represent most of the main production areas for each of the five varieties. Characteristics evaluated included time to em ergence, vigor, leaf size, leaf curl, vine maturity, disease susceptibility, insect damage, yield, specific gravity, and abiotic stressors (frost, hail, heat, herbicide, and wind) ( Simplot, 2013b )

. Five events (F37, E12, E24, G11 and H37) had statistically significant increased plant vigor, but the relative difference w as small. Five events (F10, F37, E24, G11 and H37) had significant reductions in total yield. There was no obvious correlation between decreased yield and increased disease or pest stress except possibly for event G11, since greater insect stress was obs erved than in the parental control at four of 48 insect observations on this event. Event J55 had significantly reduced early emergence ( Simplot, 2013b ) . However, no differences were detected between the transformed potato lines and conventional potato in growth, reproduction, or interactions with pests and diseases, t hat would indicate a significant change in agronomic practices would be necessary for the commercial production of these transformed lines ( Simplot, 2013b )

. Potatoes are not known to be weedy or persistent; they are incapable of survival outside of cultivation ( Holm et al. , 1979 ; Muenscher, 1980 ; Love, 1994 ; OECD, 1997 ) . Potato tubers have a fairly low frost tolerance; shallow tubers and those exposed to the surface are often destroyed by frost, but in temperate climates up to 20% of tubers left in the soil show no dormancy and will sprout the next

season ( Andersson and de Vicente, 2010 ) . Volunteer potatoes, growing from overwintered tubers, can be a weed problem in the following crop but are easily controlled with cultivation and herbicid es and do not persist as weeds for more than a few years ( Andersson and de Vicente, 2010 )

. The data presented by Simplot demonstrate that Simplot InnateTM p otato is, for the most part , phenotypically and agronomically similar to the respective parent varieties and do no t exhibit meaningful changes in characteristics that would make them weedier or more persistent than their respective parent varieties ( Simplot, 2013b ) . Because of the reductions in emergence and yield, some of the Simplot InnateTM p otato events appear to have a reduced potential for weediness ( USDA

- APHIS, 2013a ) . Furthermore, JR Simplot did not observe any differences during the completed post

- harvesting volunteer monitoring of the Simplot InnateTM p otato field test sites from 3 years of field testing that would indicate that these potatoes have properties that would increase their survivability compared to conventional potatoes. Volunteers were rarely observed, were easily controlled, and are not engineered for resistance to herbicides ( Simplot, 2013b ) . Based on the agronomic field data and literature survey concerning weediness potential of the crop, APHIS has determined that the Simplot

80InnateTM p otato is unlikely to persist as a troublesome weed or to have an impact on current weed management practices ( USDA

- APHIS, 2013a )

. APHIS evaluated the po tential of Simplot InnateTM p otato to cross with native plants and listed species, and the possibility that such crosses could result in hybrids that could affect critical habitat. As discussed thoroughly in sections 2.4.3 and 4.4.3 Gene Flow and Weediness , APHIS has determined that there is little risk of gene flow to related plant species and no risk to unrelated plant species from the cultivation of Simplot InnateTM p otato. The events derived from Russet Burbank produces few flowers and is male sterile, and those derived from variety “H” are completely sterile ( Simplot, 2013b ) . The events derived from Ranger Russet, Atlantic, and “G” are likely to produce fertile pollen, but this should have little consequence in regards to gene flow to related plants. Among nati ve Solanum spp. in the US, cultivated potato is potentially sexually

- compatible only with two tuber

- bearing species, S. jamesii and S. stoloniferum (previously S. fendleri ( Spooner et al. , 2004 ) . These two species are found only in Texas, New Mexico, and Arizona, and S. jamesii is further found in Colorado and Utah. In some cases these species are found in counties with commercial potato production ( Simplot, 2013b ) , ( USDA

- NRCS, 2013b ; 2 013a ) As discussed thoroughly in the PPRA, numerous biological and geographic obstacles make gene flow from these cult ivated potato varieties to the two wild relatives a highly unlikely occurrence, and there have been no reports that such crosses have ever occurred naturally ( Love, 1994 ) . However, because it is scientifically plausible that cultivated potatoes could hybridize with S. stoloniferum, the PPRA considered the potential impact o n the weediness of S. stoloniferum if gene introgression from Simplot InnateTM p otato were to occur. The resulting analysis concluded that the novel phenotypes (low acrylamide potential and reduced black spot bruise) did not impart any significant change i n the agronomic properties or response to biotic or abiotic stresses that would cause them to be more weedy ( USDA

- APHIS, 2013a )

. A review of the USFWS database of listed species indicates that there are three species of the Solanaceae family in the genus Solanum that are listed as endangered. Aiakeakua pop olo ( S. sandwicense ) and popolo ku mai ( S. incompletum ) both found only in Hawaii, and Erubia ( S. drymophilum ) found only in Puerto Rico. There are also two candidate species: popolo ( S. nelsonii ) found only in Hawaii, and marron bacora ( S. conocarpum ) f ound only in the U.S. Virgin Islands ( USFWS, 2014a )

. Crosses between these species and Simplot InnateTM p otato would be highly unlikely because these species are not fo und in areas of potato production and even if they were found together, crosses would be unlikely because the biology of potato as described in sections 2.4.3 and 4.4.3 Gene Flow and Weediness, and in the PPRA ( USDA

- APHIS, 2013a )

. Based on agronomic field data, literature surveyed on potato weediness potential, and the unlikelihood of crosses with wild relatives, APHIS has concluded that Simplot InnateTM p otato will have no effect on threatened or endangered plant species or critical habitat.
Threatened and Endangered Animal Species

81For its effects analysis on TES animal species, APHIS focused on the likelihood of species to be exposed to Simplot InnateTM p otato and possible effects that could occur as a result of such contact. Exposure of TES species to Simplot InnateTM p otato is only likely if the species occur in the areas where potato is grown, because potato plant parts (seeds, tubers, pollen, vegetatio n, crop debris) are not readily transported long distances without human intervention. Threatened and endangered animal species that may be exposed to Simplot InnateTM p otato would be those TES that inhabit potato fields and may feed on Simplot InnateTM p ot ato. Few if any TES are likely to use potato fields because they do not provide suitable habitat. In general, the majority of threatened and endangered species are found in more natural habitats ( USFWS, 2011 )

. Little information can be found concerning threatened or endangered species in farm fields, especially potato fields. In an Environmental Assessment on the use of genetically engineered corn and soybean in refuges in the mid

- wes t, the USFWS reported that whooping crane ( Grus americana ), sandhill crane ( Grus canadensis pulla ), piping plover ( Charadrius melodus ), interior least tern ( Sterna antillarum ), and Sprague’s pipit ( Anthus spragueii; a candidate species) occasionally feed i n farmed sites ( USFWS, 2011 )

. Although it is possible that these bird species may visit potato fields during migratory periods, it is unlikely they would be present during normal farmi ng operations ( USFWS, 2011 ) . USDA

- APHIS Wildlife Services has received complaints for damage to corn, wheat, and potatoes caused by sandhill cranes ( USDA

- APHIS, 2013 c )

. As discussed in Section 2.4.1 , Animal Communities, there are few animals reported to consume potato plants in an agricultural setting. This is not surprising considering the foliage and stems of potato contain toxic glycoalkaloids known to cause i llness when consumed ( Sinden, 1987 ) . Kn own exceptions are whitetail deer, wild boar, and voles ( Marinette County, 2014 ) , ( O'Brien, 2005 ; Taylor, 2014 ) . There are two listed sub

- species of white

- tailed deer and three listed vole species within States that have commercial potato production. The Columbia white

- tailed deer ( Odocoileus virginianus leucurus ) has two populations; one population in Douglass County, Oregon was delisted in 2003. The other, listed as endangered, is located in the lower Columbia River Valley in Washington State ( USFWS, 1983 ) . Neither population is found in areas of significant potato prod uction as indicated in Figure 1, Potato Growing Regions of the U.S. ( USDA

- NASS, 2007 ) . The endangered Key deer ( Odocoileus virginianus clavium ) is found only on the extreme tip of southern Florida far from any commercial potato production ( USFWS, 2014c ) . The three vole species are listed as endangered. The Amargosa vole ( Micro t us californicus scirpensis ) is found in Inyo County in southeast California which is not an area of potato production ( USFWS, 2014b ) . The Florida salt marsh vole ( Microtus pennsylvanicus dukecampbelli ) is found in saltmarshes of Levy Count y in coastal Florida, also not in areas of potato production ( USFWS, 2014d )

. The Hualapai Mexican Vole ( Microtus mexicanus hualapaiensis ) is found in Mohave County, Arizona, where potatoes are a minor crop. However, the species would be unlikely to be found in potato fields because it is found only in woodlands and grasslands in the canyons of the Hualapai Mountains ( USFWS, 1991 )

. Although unlikely, APHIS considered the possible effects on TES if they were to consume Simplot InnateTM p otato. Detailed compositional analyses of the ten events are found in Appendix 9 of the 82petition. The compositional assessments determined the amount s of 1) moisture, protein, total fat, ash, crude fiber, carbohydrate and calories; 2) vitamins B6, B3 and C; 3) minerals copper, magnesium and potassium; 4) glycoalkaloids; 5) free amino acids; and 6) total amino acids for tubers collected from events grow n in 2009, 2010, and 2011 in potato

- growing areas of the United States ( Simplot, 2013b )

. The potato events described in the petition were found to be no different compositionally when compared to untransformed controls, except for the intended traits ( Simplot, 2013b ) . As di scussed in Section 4. 6

. 1 , Human Health, issues with allergies to Simplot InnateTM p otato would be unlikely beyond what individuals with potato allergies would normally experience. The modifications did not alter the quality of potato as food other than lo wer levels of acrylamide after cooking, and lower black spot bruise. Simplot submitted a safety and nutritional assessment of food and feed derived from Simplot InnateTM p otato to the FDA on February 12, 2013 ( BNF No. 141) ( Simplot, 2013b )

. FDA is presently evaluating the submission.

As discussed in Section 4.4.1 , Animal Communities, there are a large number of insects that feed on potato leaves and other insects that feed on those pests. No differences were observed for insects or other animals interacting within the potato ecosystem during the field trials, leading to the conclusion that Simplot InnateTM potatoes would have the same impact on other organisms as conventional potatoes ( Simplot, 2013b )

. There is no evidence that animal exposure to S implot InnateTM p otato would have any effect or be any less attractive as food, refuge, cover and nesting sites as non GE varieties of potatoes.
APHIS considered the possibility that Simplot InnateTM p otato could serve as a host plant for a threatened or endangered species. A review of the species list reveals that there are no members of the genus Solanum that serve as a host plant for any threatened or endangered species ( USDA

- APHIS, 2014a ; 2014b )

. Considering the lack of expected exposure , and the expectation that exposure would not produce response s any different than potato varieties currently in production, cultivation of Simplot I nnateTM p otatoes an d their progeny are expected to have no effect on threatened or endangered animals.
Summary
After reviewing the possible effects of allowing the environmental release of Simplot InnateTM p otato
, APHIS has not identified any stressor that could affect the reproduction, numbers, or distribution of a listed TES or species proposed for listing. APHIS also considered the potential effect of a determination of nonregulated status of Simplot InnateTM p o tato on designated critical habitat and habitat proposed for designation, and could identify no differences from effects that would occur from the production of other potato varieties. Potato is not considered a competitive plant species and has been sele cted for domestication and cultivation under conditions not normally found in natural settings ( Holm et al. , 1979 ; Muenscher, 1980 ; Love, 1994 ; OECD, 1997 ) . There is no ability of Simplot InnateTM p otato to nat urally hybridize with any wild Solanum species, including listed species. Simplot InnateTM p otato will not serve as a host species for any listed species or species proposed for listing. Consumption of Simplot InnateTM p otato by any listed species or speci es proposed for listing will not result in a toxic or allergic reaction.
83Based on these factors, APHIS has concluded that a determination of nonregulated status of Simplot InnateTM p otato
, and the corresponding environmental release of these potato events will have no effect on listed species or species proposed for listing, and would not affect designated habitat or habitat proposed for designation. Because of this no

- effect determination , consultation under Section 7(a)(2) of the Act or the concurrences of the USFWS or NMFS is not required.

847 CONSIDERATION OF EXE CUTIVE ORDERS, STAND ARDS, AND TREATIES R ELATING TO ENVIRONMENTAL IMPACT S

7.1 Executive Orders with Domestic Implications

The fol lowing executive orders require consideration of the potential impacts of the Federal action to various segments of the population.

• Executive Order (EO) 12898 ( U S

- NARA, 2010 ) , "Federal Actions to Address Environmental Justice in Minority Populations and Low

- Income Populations," requires Federal agencies to conduct their programs, policies, and activities that substantially affect human health or the environment in a manner so as not to exclude persons and populations from participation in or benefiting from such programs. It also enforces existing statutes to prevent minority and low

- income communities from being subjected to disproportionately high and adverse human health or environmental effects.

• EO 13045, “Protection of Children from Environmental Health Risks and Safety Risks,” acknowledges that children may suffer disproportionately from environmental health and safety risks because of their developmental stage, greater metabolic activity levels, and behavior patterns, as compared to adults. The EO (to the extent permitted by law and consistent with the agency’s mission) requires each Federal agency to identify, assess, and address environmental health ri sks and safety risks that may disproportionately affect children.

Neither t he No Action nor the Preferred Alternative is expected to have a disproportionate adverse effect on minorities, low

- income populations, or children because Simplot InnateTM p otato events

are agronomically, phenotypically, and biochemically similar to conventional potatoes except for the low acrylamide potential and reduced black spot bruise trait s

. To establish that the new cultivars are nutritionally equivalent to their parent cul tivars, Simplot InnateTM potato and the control Ranger Russet potato were subjected to nutritional and proximate analysis, and measured for free amino acids, total amino acids, glycoalkaloids, sugars, and acrylamide levels. This means they are not likely t o have adverse effects on individuals within those populations when they are consumed. At present, studies suggest that potatoes represent over 30 % of vegetable consumption in U.S. children in and out of school ( Olsho and Fernandes, 2013 ) and that urban /minority youths are more likely to consume more fried potato products than youths living in a non

- urban environment ( Davis and Carpenter, 2009 )

. Olsho and Fernandes ( 2013 ) suggest that the targeting of potato preparation methods may represent a more viable method to improve the healthfulness of potato dishes, and as such, the int roduction and use of Simplot Innate TM potato may improve any disparate adverse effect associated with potato consumption in the United States.

Reduced free asparagine (ASN) and total ASP + ASN, increased free GLN and total GLU + GLN, reduced acrylamide , and lowered reducing sugars were observed and expected as a result of gene 85silencing. This reduction c ould benefit consumers by addressing a food safety issue in potato industry ( NTP, 2011 ) . Other unexpected significant differences were reported, but t he values are all within the normal ranges for potatoes . J3 tubers contained an average of 0.117 mg/100 g pyridoxine (vitamin B6) as compared to the controls, which had 0.124 mg/100g. J55 also had decreased pyridoxine. J3 tubers had an average of 134 pp m of free VAL as compared to the controls, which had 147 ppm. J55 also experienced decreased VAL; H37 had decreased LYS; F37 had increased free ARG; G11 had increased total LYS and PRO; F10 and F37 had increased vitamin C and niacin; E12 and E24 had decre ased sucrose; and H37 had increased sucrose. These deviations in various amino acids and vitamins, while experimentally significant, do not exceed the range of variation observed in conventional potato varieties ( USDA

- APHIS, 2013a )

.
Potatoes also were tested for reducing sugars and acrylamide after storage. Many of the events had lowered levels of reducing sugars at the time of harvest or one month of storage, but significant differences were not routinely o bserved after 2

- 5 months compared to conventional potato varieties . Storage up to 7 months yielded consistently lower acrylamide levels in most events than in the controls, although there were exceptions with the G and H varieties. Overall, the modificat ions from insertion of pSIM1278 resulted in reductions in acrylamide that persisted throughout the storage period.

Research confirmed that the overall levels of natural glycoalkaloids, a tox in commonly found in solanaceous crops including potato, were no t increased in the Simplot Innate TM events. The safety limit is 20mg/100g as described by Sinden ( 1987 )

. There were, however, higher mean levels of glycoalkaloids in the G event (20.3 mg/100g) and the comparative untransformed control (19.8 mg/100g), but this was attributed to addition al handling at the storage sites and subsequent exposure to light and temperature fluctuations ( Simplot, 2013b )

. As presented in the APHIS PPRA (2013a), while some Simplot Innate TM potato events exhibited higher glycoalkaloid content (e.g., G event) , its respective controls also exhibited higher glycoalkaloid levels and that these observed concentrations of glycoalkaloids still remain in the range of typical potato glycoalkaloid levels described in the literature. This finding suggests that there are no safety concerns with Simplot Innate TM potato due to similarities in composition

.

Patatin is a potato storage glycoprotein that makes up approximately 40 percent of the soluble protein in tubers. Although patatin was not measured during the studies ( Simplot, 2013b ) , any potential exposure to patatin is not expected to be different as a result of a determination of nonregulated status for Simplot Innate TM potato. Some allergies have been detected in children as a result of patatin; however, these allergies are only in children and are uncommon ( De Swert et al. , 2002 ; 2007 ) . Children who are allergic to potatoes would avoid potatoes under the No Action Alternative; therefore, any changes in patatin levels in Simplot InnateTM potato would not impact these children, as they are already avoiding potatoes due to the high proport ion of patatin already occurring in conventional potato varieties ( Mignery et al. , 1988 )

.

86In summary, the compositional data presented in the Simplot petition (2013a) and analyzed in the APHIS PPRA (2013a) indicates that Simplot Innate TM potato does not substantially differ from conventional potato varieties with the exception of the introduced traits. As a result, Simplot Innate TM potato is not expected to hav e a disproportionate adverse effect on minorities, low

- income populations, or children

.
Simplot initiated the consultation process with FDA for the commercial distribution of Simplot InnateTM p otato and submitted a safety and nutritional assessment of food and feed derived from Simplot InnateTM p otato to the FDA ( Simplot, 20 13b ) . FDA is presently evaluating the submission.
The following executive order addresses Federal responsibilities regarding the introduction and effects of invasive species:

EO 1311 ( US

- NARA, 2010 ) , “Invasive Species,” states that Federal agencies take action to prevent the introduction of invasive species, to provide for their control, and to minimize the economic, ecological, and human health impacts that invasive species

cause.
Based on historical experience with potatoes and data submitted by the applicant and revi ewed by APHIS, Simplot InnateTM p otato is not expected to become weedy or invasive. Potatoes are not listed in the United States as a n oxious weed species by the Federal government (7 CFR Part 360 ) ( USDA

- NRCS, 2014 ) , nor is it listed as a n invasive species by major invasive plant databases. Standard potato

- growing practices make it highly unlikely that potatoes would persist in a field from one crop cycle to the next. In areas where potatoes are grown as a rotation crop, any potatoes lef t in the field generally are eliminated by tilling, field preparations with herbicides, and harsh winters. To maximize an economic return, p otato growers rarely leave the ground fallow

. A ny potatoes inadvertently growing in a fallow field are not protected with insecticide s or fungicide s; they would be susceptible to the Colorado potato beetle and early blight , and likely die

. Potatoes are not known to escape from fields (become feral) or show weediness potential. Potato seedlings grown from tuber s have difficulty establishing because they are poor competitors against grasses, trees, and shrubs. T he traits incorporated into Simplot InnateTM p otato are not associated with weediness and these traits will not help plants thrive outside of cultivation.
The following executive order requires the protection of migratory bird populations:

EO 13186 ( US

- NARA, 2010 ) , “Responsibilities of Federal Agencies to Pro tect Migratory Birds,” states that federal agencies taking actions that have, or are likely to have, a measurable negative effect on migratory bird populations are directed to develop and implement, within two years, a Memorandum of Understanding (MOU) wit h the Fish and Wildlife Service that shall promote the conservation of migratory bird populations.

87APHIS has in place a signed MOU with the FWS ( USDA

- APHIS and USFWS, 2012 ) . In accordance with this MOU, APHIS has considered the potential impacts of InnateTM potato on migratory birds.
Based on historical experience with potatoes and data submitted by the applicant and revi ewed by APHIS, Simplot InnateTM p otato is expected to have the same interactions with migratory birds as conventional potatoes. The applicant provided data to demonstrate the compositional equivalency of InnateTM p otato and other potato varieties currently grown. T he modifications did not alter the quality of potato as food other than lower levels of acrylamide after cooking, and lower black spot bruise. There would be no effect from consumption of InnateTM potato plant parts because there is nothing different betwe en the plant parts of these varieties and plant parts of other potato varieties already in production. Migratory birds are not attracted to potato fields for potatoes; however, waterfowl forage extensively in agricultural fields in the fall and winter and are at risk for exposure to pesticides. In addition, raptors are at risk of exposure to pesticides if they consume dead or dying waterfowl from the fields. With regard to pesticide use, the ten Simplot InnateTM p otato events are similar to their conventi onal cultivated potato counterparts , and therefore would not require additional use of pesticide applications. No “take” of a migratory bird is expected as a result of growing InnateTM p otato, and APHIS could not determine any mechanism by which take would occur, or would occur any differently than production of any other potato variety.

7.2 International Implications

EO 12114 ( US

- NARA, 2010 ) , “Environmental Effects Abroad of Major Federal Actions” requires agencies to consider the potential environmental effects outside the U.S., its territories, and possessions for proposed federal actions

. APHIS does not expect a significant environmental impact outside th e U nited S tates in the event of a determination of nonregulated status of Simplot InnateTM p otato because existing national and international regulatory authorities and phytosanitary regimes will apply.
Any international trade of Simplot InnateTM p otato su bsequent to a determination of nonregulated status of the product would be fully subject to national phytosanitary requirements and be in accordance with phytosanitary standards developed under the International Plant Protection Convention ( IPPC, 2010 ) . In April 2004, a standard for PRA of living modified organisms (LMOs) was adopted at a meeting of the governing body of the IPPC as a supplement to an existing standard, International Standard for Phytosanitary M easure No. 11 (ISPM

- 11, Pest Risk Analysis for Quarantine Pests). Th is standard acknowledges that all LMOs will not present a pest risk and that a determination needs to be made early in the PRA for importation as to whether the LMO poses a potential pest risk resulting from the genetic modification. APHIS pest risk assessment procedures for genetically engineered organisms are consistent with the guidance developed under the IPPC.

I ssues that may relate to commercialization and transboundary movement o f particular agricultural commodities produced through biotechnology are addressed through treaties, in international forums , and through national regulations. These sources include the North American Plant Protection Organization (NAPPO), the Organization for Economic Cooperation and Development (OECD), and the
88North American Biotechnology Initiative (NABI), among others

. For example, t he Cartagena Protocol o n Biosafety is a treaty under the United Nations Convention on Biological Diversity (CBD) that established a framework for the safe transboundary movement, with respect to the environment and biodiversity, of LMOs, which include those modified through biot echnology. E xporters need to comply with the regulations that importing countries wh o are Parties to the Protocol have promulgated. The first intentional transboundary movement of LMOs intended for environmental release (field trials or commercial planti ng) will require consent from the importing country under an advanced informed agreement (AIA) provision, which includes a requirement for a risk assessment consistent with Annex III of the Protocol and the required documentation.
LMOs imported for food, f eed, or processing (FFP) are exempt from the AIA procedure, and are covered under Article 11 and Annex II of the Protocol. Under Article 11, Parties must post decisions to the Biosafety Clearinghouse database on domestic use of LMOs for FFP that may be su bject to transboundary movement. To facilitate compliance with obligations to this protocol, the Federal g overnment developed a website that provides the status of all regulatory reviews completed for different uses of bioengineered products ( NBII, 2010 ) . The applicable data used in analyses of Simplot InnateTM p otato events will be available to the Biosafety Clearinghouse.
7.3 Compliance with Clean Water Act and Clean Air Act
This EA evaluated the potential changes in potato production associated with a determination of nonregul ated status of Simplot InnateTM p otato (Section 4.2) and determined that the cultivation of Simplot InnateTM p otato would not lead to the increased production or acreage of potato in U.S. agricul ture. The ten Simplot InnateTM p otato events do not possess traits that would allow them to be grown in areas other than those wh ere their conventional counterparts are grown. The low acrylamide potential and reduced black spot bruise trait conferred by the genetic m odification to Simplot InnateTM p otatoes would not result in any changes in water usage for cultivation. As discussed in Section 4.3, there are no expected negative impacts to water resources or air quality a ssociated with Simplot InnateTM p otato production. Based on these analyses, APHIS concludes that a determination of nonregul ated status of Simplot InnateTM p otatoes w ould comply with the Clean Water Act and the Clean Air Act.
7.4 Impacts on Unique Characteristics of Geographic Areas

This EA determined the cultivation of Simplot InnateTM p otato would not lead to the increased production or acreage of potato in U.S. agriculture because t he ten Simplot InnateTM p otato events do not possess traits that would allow them to be grown in areas other than those where their conventional counterparts are grown. The low acrylamide potential and reduced black spot bruise trait conferred by the genetic modification to Sim plot InnateTM p otatoes would not result in any changes in water usage for cultivation. As discussed in Section 4.3, there are no expected negative impacts to water resources or air quality a ssociated with Simplot InnateTM p otato production. Based on these

89analyses, APHIS concludes that a determination of nonregul ated status of Simplot InnateTM p otatoes would comply with the Clean Water Act and the Clean Air Act.

7. 5 Impacts on Unique Characteristics of Geographic A reas

This EA determined the cultivation of Simplot InnateTM p otato would not lead to the increased production or acreage of potato in U.S. agriculture because t he ten Simplot InnateTM p otato events do not possess traits that would allow them to be grown in a reas other than those where their conventional counterparts are grown. A determination of nonregulated status f or Simplot InnateTM p otatoes is not likely to lead to impacts to unique characteristics of geographic areas because these varieties lack characte ristics of weediness and lack pollen that is wind

- borne over long distances. In particular, their water

- use characteristics do not suggest an ability to invade riparian areas or wetlands.

7. 6 National Historic Preservation Act (NHPA) of 1966 as Amended
The NHPA of 1966 and its implementing regulations (36 CFR 800) require Federal agencies to: 1) determine whether activities they propose constitute "undertakings" that have the potential to cause effects on historic properties and 2) if so, to evaluate th e effects of such undertakings on such historic resources and consult with the Advisory Council on Historic Preservation (i.e., State Historic Preservation Office, Tribal Historic Preservation Officers), as appropriate.
APHIS’ proposed action, a determin ation of nonregulated status of Simplot Innate TM p otato is not expected to adversely impact cultural resources on tribal properties. Any farming activity that may be taken by farmers on tribal lands would only be conducted at the tribe’s request; thus, the tribes would have control over any potential conflict with cultural resources on tribal properties. APHIS sent letters to Tribal entities when this petition was declared complete and made available to the public. There were no comments received from any tribal entit i es.
APHIS’ Preferred Alternative would have no impact on districts, sites, highways, structures, or objects listed in or eligible for listing in the National Register of Historic Places, nor would it likely cause any loss or destruction o f significant scientific, cultu ral, or historical resources. This action is limited to a determination of non
- regulated status of Simplot Innate TM p otato

. APHIS’ proposed action is not an undertaking that may directly or indirectly cause alteration in the character or use of historic properties protected under the NHPA. In general, common agricultural activities conducted under this action do not have the p otential to introduce visual, atmospheric, or noise elements to areas in which they are used that could result in effects on the character or use of historic properties. For example, there is potential for increased noise on the use and enjoyment of a his toric property during the operation of tractors and other mechanical equipment close to such sites. A built

- in mitigating factor for this issue is that virtually all of the methods involved would only have temporary effects on the audible nature of a site and can be ended at any time to restore the audible qualities of such sites to their original condition with no further adverse effects. Additionally, these

90cultivation practices are already being conducted throughout the potato production regions. The cultivation of Simplot Innate TM p otato is not expected to change any of these agronomic practices that would result in an adverse impact under the NHPA.

918 REFERENCES
Coordinated Framework for Regulation of Biotechnology 1986. Pub. L. Stat. June 26. http://www.aphis.usda.gov/brs/fedregister/coordinated_framework.pdf

. Statement of Policy: Foods Derived from New Plant Varieties 1992. Pub. L. Stat. May 29. http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/biotec hnology/ucm096095.htm

. Altieri, M (1999) "The e cological role of biodiversity in agroecosystems." Agriculture, Ecosystems and Environment. 74 p 19

- 31. http://www.sciencedirect.com/science/art icle/B6T3Y

- 3X6JG7B

3/2/af0c7abed1c5a6c972ade218e2abe75a

. Andersson, MS and de Vicente, MC (2010) Gene flow between crops and their wild relatives . Baltimore: Johns Hopkins University Press. AOSCA (2010) "General IP Protocols Standards." The Association of Official Seed Certifying Agencies. http://www.identitypreserved.com/handbook/aosca

- general.htm

. Arif, M; Arshad, M; Zafar, Y; Mansoor, S; and Asad, S (2012) "Engineering Broad

- Spectrum Resistance Against RNA Viruses in Potato." Trangenic Research. 21 p 303

- 11. Arvanitoyannis, IS; Vaitsi, O; and Mavromatis, A (2008) "Potato: a Comparative Study of th e Effect of Cultivars and Cultivation Conditions and Genetic Modification on the Physico

- Chemical Properties of Potato Tubers in Conjunction with Multivariate Analysis toward Authenticity." Critical Reviews in Food Science and Nutrition. 48 (9): p 799

- 823. Bachem, CWB; Speckmann, GJ; Van der Linde, PCG; Verheggen, FTM; Hunt, MD; Steffens, JC; and Zabeau, M (1994) "Antisense expression of polyphenol oxidase genes inhibits enzymatic browning in potato tubers." Bio/Technology. 12 (11): p 1101

- 05. http://www.scopus.com/inward/record.url?eid=2

- s2.0

- 0028032722&partnerID=40&md5=2f2c26ad336493ff14524687e7c31512

. Baldwin, IT and Preston, CA (1999) "The eco

- physiological complexity of plant responses to insect herbivores." Planta. 208 (2): p 137

- 45. http://dx.doi.org/10.1007/s004250050543

. Bamberg, J and del Rio, A (2011) "Diversity Rela tionships among Wild Potato Collections from Seven "Sky Island" Mountain Ranges in the Southwest USA." American Journal of Potato Research. 88 p 493

- 99. Bamberg, J; del Rio, A; Huaman, Z; Vega, S; Martin, M; Salas, A; Pavek, W; Kiru, S; Fernandez, C; and Spooner, D (2003) "A Decade of Collecting and Research on Wild Potatoes of the Southwest USA." American Journal of Potato Research. 80 p 159

- 72. Bechinski, E; Bragg, J; Hafez, S; Hirnyck, R; Olson, N; Stolz, R; and Wiese, M (2001) "Crop Profile for Potato es in Idaho." http://www.ipmcenters.org/cropprofiles/docs/idpotatoes.html

. Bennett, K and O'Rourke, P (2002) "Crop Profile for Potatoes in Minnesota." North Central Pest Management Center, University of Minnesota. Board, USP (2012) http ://www.uspotatoes.com/downloads/Frozen%20Potato%20Products

Export_NEW.pdf

. Board, USP (2013) "Press Release." http://www.uspotatoes.com/pressRoom/pr.php?id=270

. Boukhettala, N; Ibrahim, A; A ziz, M; Vuichoud, J; Saudan, K

- Y; Blum, S; Dechelotte, P; Breuille, D; and Coeffier, M (2010) "A Diet Containing Whey Protein, Free Glutamine, and Transforming Growth Factor

- Beta Ameliorates Nutritional Outcome and Intestinal Mucositis during Repeated Chem otherapeutic Challenges in Rats." The Journal of Nutrition. p 1

- 7. Boydston, RA and Williams, MM (2005) "Managing Volunteer Potato (Solanum tuberosum) in Field Corn with Mesotrione and Arthropod Herbivory." Weed Technology. 19 p 443

- 50.

92Bruinsma, M; Kowa lchuk, GA; and van Veen, JA (2003) "Effects of Genetically Modified Plants on Microbial Communities and Processes in Soil." Biology and Fertility of Soils. 37 p 329

- 37. Bushway, A (2010) "The Potato as Food." Commercial Potato Production in North America: the Potato Association of America Handbook . Potato Association of America. p 9

- 12. Carroll, JE and Robinson, TL (2006) "New York Integrated Fruit Production Protocol for Apples." New York State Agricultural Experiment Station. CEPA

- OEHHA (2005) "No Sign ificant Risk Level (NSRL) of the Proposition 65 Carcinogen Acrylamide

. " Agency, California Environmental Protection. Last Accessed: April 30, 2013 http://oehha.ca.gov/prop65/law/pdf _zip/Acrylamide_NSRL.pdf

. Chawla, R; Shakya, R; and Rommens, C (2012) "Tuber

- Specific Silencing of Asparagine Synthetase

- 1 Reduces the Acrylamide

- Forming Potential of Potatoes Grown in the Field without Affecting Tuber Shape and Yield." Plant Biotechnology Journal. 10 p 913

- 24. Conner, AJ and Dale, PJ (1996) "Reconsideration of Pollen Dispersal Data from Field Trials of Transgenic Potatoes." Theoretical and Applied Genetics. 92 p 505

- 08. Corbett, R (No Date) "Feeding Potatoes to Livestock." University of Maine Cooperative Extension. http://www.umaine.edu/umext/potatoprogram/Fact%20Sheets/FeedingLivestock.pdf

. Cornell University (2013) "2013 Production Guide for Or ganic Potatoes." Corsini, D; Stark, J; and Thornton, M (1999) "Factors Contributing to the Blackspot Bruise Potential of Idaho Potato Fields." American Journal of Potato Research. 76 (4): p 221

- 26. http://www.scopus.com/inward/record.url?eid=2

- s2.0

- 0032790557&partnerID=40&md5=d65f7abc50fadd5b47d6423ed9633913

. Davidson, R (2010) "Selecting, Storing, Preparing and Planting Seed." Co mmercial Production of Potatoes in North America: the Potato Association of America Handbook . Potato Association of America. p 38

- 44. Davis, B and Carpenter, C (2009) "Proximity of Fast

- Food Restaurants to Schools and Adolescent Obesity." American Journal of Public Health. 99 (3): p 505

- 10. De Swert, LFA; Cadot, P; and Ceuppens, J (2002) "Allergy to Cooked White Potatoes in Infants and Children: a Cause of Severe, Chronic Allergic Disease." Journal of Allergy and Clinical Immunology. 110 (3): p 524

- 29. D e Swert, LFA; Cadot, P; and Ceuppens, J (2007) "Diagnosis and Natural Course of Allergy to Cooked Potatoes in Children." Allergy. 62 p 750

- 57. DEFRA (2006) "Environmental Impacts of Food Production and Consumption." University of Manchester Business Schoo l. http://www.ifr.ac.uk/waste/Reports/DEFRA

Environmental%20Impacts%20of%20Food%20Production%20%20Consumption.pdf

. Delahaut, KA ( 2000) "Crop Profile for Potatoes in Wisconsin." University of Wisconsin. http://www.ipmcenters.org/cropprofiles/docs/wipotatoes.pdf

. Dimitri, C and Oberholtzer, L (2005) "Market

- Led Growth vs. Government

- Facilitated Growth: Development of the US and EU Organic Agricultural Sectors." USDA Economic Research Service. Dimitri, C and Oberholtzer, L (2009) "Marketing E.S. Organic Foods, Recent Trends From Farms to Consumers." USDA

- ERS. http://www.ers.usda.gov/media/185272/eib58_1_.pdf

. Dirks

- Hofmeister, ME; Kolkenbrock, S; and Moerscher, BM (2013) "Parameters that Enhance the Bacterial Expression of Active Plant Polyphenol O xidases." PLoS One. 8 (10): p e77291. Doran, JW; Sarrantonio, M; and Liebig, MA (1996) "Soil Health and Sustainability." Advances in Agronomy. 56 p 1

- 54. Dufour, R; Hinman, T; and Shachzenski, J (2009) "Potatoes: Organic and Production and Marketing." Na tional Sustainable Agriculture Information Service.

93Eberlein, CV; Boydston, RA; Thornton, M; Larkin, M; and Seymour, M (1998) "Volunteer Potato Control." University of Idaho Cooperative Extension System. http://www.cals.uidaho.edu/edcomm/pdf/cis/cis1048.pdf

. Esplin, K (2009) "Organic Russet Marketing Challenges." Potato Growers of Idaho. http://www.pesticide.org/get

- the

- facts/ncap

- publications

- and

- reports/sustainable

agriculture/organicpotatoupdate

- summer2009.pdf

. Everman, W and Long, C (2010) "Volunteer Potatoes." Michigan State University. http://ipmnews.msu.edu/fieldcrop/fieldcrop/tabid/56/articleType/ArticleView/articleId/26

. FAO (2008) "International Year of the Potato 2008: New Light on a Hidden Treasure." Food and Agriculture Organization of the United Nations. http://www.fao.org/potato

- 2008/pdf/IYPbook

en.pdf

. FAO/WHO (2011) "WHO Additive Food Series 63: Safety Evaluation of Certain Contaminants in Food." World Health Organization Food and Agriculture Organization of the United Nations. http://www.google.com/url?sa=t&rct=j& q=&esrc=s&frm=1&source=web&cd=1&ved=0CB8QFjA A&url=http%3A%2F%2Fwhqlibdoc.who.int%2Fpublications%2F2011%2F9789241660631_eng.pd f&ei=_J7jU_f3L8nAigLt8oAg&usg=AFQjCNHIKLxiLa5okGEp3qtjTw5x4WeIbw&sig2=1P6A

-- jeyKyOgH9cokh2VQ&bvm=bv.72676100,d.cGE

. Faust, M (2002) "New feeds from genetically modified plants: the US approach to safety for animals and the food chain." Livestock Production Science. 74 (3): p 239

- 54. FDA (2009) "Acrylamide in Food; Request for Comments and Scientific Data and Information." Federal Reg ister. http://www.gpo.gov/fdsys/pkg/FR

- 2009

- 08

- 26/html/E9

- 20495.htm

. FDA (2013a) "Guidance for Industry: Acrylamide in Foods, Draft Guidance." Food and Drug Administration. http://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInfor matio n/ChemicalContaminantsMetalsNaturalToxinsPesticides/UCM374534.pdf

. FDA (2013b) "You Can Help Cut Acrylamide in Your Diet." Food and Drug Administration. http://www.fda.gov/forcon sumers/consumerupdates/ucm374855.htm

. Felton, GW; Donato, K; Del Vecchio, RJ; and Duffey, SS (1989) "Activation of Plant Foliar Oxidases by Insect Feeding Reduces Nutritive Quality of Foliage for Noctuid Herbivores." Journal of Chemical Ecology. 15 (12): p 2667

- 94. Flachowsky, G; Chesson, A; and Aulrich, K (2005) "Animal nutrition with feeds from genetically modified plants." Archives of Animal Nutrition. 59 (1): p 1

- 40. Last Accessed: April 20, 2011 http://www.informaworld.com/10.1080/17450390512331342368

. Foods, K (2009) "Organic Chips." www.kettlebrand.com/our_products/organic_chips

. Friedman, M (1997) "Chemistr y, Biochemistry, and Dietary Role of Potato Polyphenols. A Review." Journal of agricultural and food chemistry. 45 (5): p 1523

- 40. http://www.scopus.com/inward/record.url?eid=2

- s2.0

- 0642271751&partnerID=40&md5=c648dc51b85f5c83ebe2ad2ef86c5ba1

. Friedman, M (2003) "Chemistry, Biochemistry, and Safety of Acrylamide: a Review." Journal of agricultural and food chemistry. 51 p 4504

- 26. FWS (2011) "Listed Plants." http://ecos.fws.gov/tess_public/pub/listedPlants.jsp

. Garbeva, P; van Veen, J; and van Elsas, JD (2004) "Microbial Diversity in Soil: Selection of Microbial P opulations by Plant and Soil Type and Implications for Disease Suppressiveness." Annual Review of Phytopathology. 42 p 243

- 70. Guenther, J (2010a) "Marketing and Economics." Commercial Potato Production in North America: the Potato Association of America Handbook . Potato Association of America. p 13

- 15.

94Guenther, J (2010b) "Processing Markets." Commercial Potato Production in America: the Potato Association of America Handbook . p 17. Guenther, J (2010c) "Utilization." Commercial Potato Production in Nort h America: the Potato Association of America Handbook . Potato Association of America. p 15

- 16. Halford, NG; Curtis, TY; Muttucumaru, N; Postles, J; Elmore, JS; and Mottram, DS (2012a) "The Acrylamide Problem: a Plant and Agronomic Science Issue." Journal of Experimental Biology. 63 (8): p 2841

- 51. Halford, NG; Muttucumaru, N; Powers, SJ; Gillatt, PN; Hartley, L; Elmore, JS; and Mottram, DS (2012b) "Concentrations of Free Amino Acids and Sugars in Nine Potato Varieties: Effects of Storage and Relationship with Acrylamide Formation." Journal of Agricultural and Food Chemistry. 60 p 12044

- 55. Hall, K; Holloway, RL; and Smith, DT (2000) "Texas Crop Profile: Potatoes." Texas Agricultural Extension Service. http://liveoak.agrilife.org/files/2011/07/TxCropProfilePotatoes_7.pdf

. Hardy, B (1996) "Major Potato Diseases, Insects, and Nematodes." International Potato Center. http://cipotato.org/resources/publications/book/major

- potato

- diseases

- insects

- and

nematodes/

. Harlan, JR (1975) "Our vanishing genetic resources." Science

. 188 (4188): p 618

- 21. Hijmans, RJ and Spooner, D (2001) "Geographic Distribution of Wild Potato Species." American Journal of Botany. 88 (11): p 2102

- 12. Hollingsworth, D (No Date) "Growing Potatoes Organically: Basics from Seed to Storage." University of California at Davis. Holm, LG; Pancho, JV; Herberger, JP; and Plucknett, DL (1979) A geographical atlas of world weeds

. Krieger Publishing Company. Hoopes, RW and Plaisted, RL (1987) "Potato." Principles of Cultivar Development . New York: Macmillan. Hopkins, BG (2010) "Rotations." Commercial Potato Production in North America: the Potato Association of America Handbook . p 34

- 35. Hopkins, BG; Hutchinson, PJS; Patterson, P; Miller, J; Thornton, M; Hafez, S; and Alvarez, J (2004) "Cropping Sequence and Rotation: Impact on Potato Production and Soil Condition." p 1

- 13. Idaho. Hunt, MD; Eannetta, NT; Yu, H; Newman, SM; and Steffens, JC (1993) "cDNA cloning and expression of potato polyphenol oxidase." Plant Molecular Biology. 21 (1): p 59

- 68. http://www.scopus.com/inward/record.url?eid=2

- s2.0

- 0027342468&partnerID=40&md5=b6156a43898d59b4ca9950328832d520

. Hutchinson, PJS (2010) "Weed Control." Commercial Potato Production in North America: the Potato Association of America Handbook . Potato Association of America. p 62

- 64. Inceoglu, O; van Overbeek, LS; Falcao Salles, J; and van Elsas, JD (2013) "Normal Ope rating Range of Bacterial Communities in Soil Used for Potato Cropping." Applied and Environmental Microbiology. 79 (4): p 1160

- 70. IPC (2010) "Facts and Figures about Potato." International Potato Center. http://cipotato.org/resources/publications/fact

- sheets

- flyer

- leaflet/facts

- and

- figures

- about

sweetpotato/

. IPPC (2010) "Official web site for the International Plant Protection Conven tion: International Phytosanitary Portal " International Plant Protection Convention. https:// www.ippc.int/IPP/En/default.jsp

. Johnson, DA (2007) Potato Health Management . St. Paul: American Phytophath ological Society. Johnson, SB (2010) "Harvesting the Crop." Commercial Potato Production in North America: the Potato Association of America Handbook . Potato Association of America Handbook. p 75. 95Johnson, SB and Sideman, E (2006) "Potato Facts: Producin g Potatoes Organically in Maine." University of Maine Cooperative Extension. http://www.umaine.edu/umext/potatoprogram/Fact%20Sheets/organic%20potatoes.pdf

. John son, SB; Stevenson, W; and Miller, J (2010) "Disease Control." Commercial Potato Production in North America: the Potato Association of America Handbook . Potato Association of America. p 67

- 72. King, BA and Stark, JC (No Date) "Potato Irrigation Managemen t." University of Idaho Cooperative Extension System. http://www.cals.uidaho.edu/edcomm/pdf/BUL/BUL0789.pdf

. Kleinkopf, G (2010) "Sprout Control in Storage." Commercial Potato Production in North America: the Potato Association of America Handbook . Potato Association of America. p 85. Klimberg, VS; Souba, WW; Dolson, DJ; Hautamaki, RD; Mendenhall, WM; Khan, SR; and Bland, KI (1990) "Prophylactic Glutamine Protects the Intestinal Mucosa f rom Radiation Injury." Cancer. 66 (1): p 62

- 68. Kotsiou, K; Tasioula

- Margari, M; Fiore, A; Gokmen, V; and Fogliano, V (2013) "Acrylamide Formation and Colour Development in Low

- Fat Baked Potato Products as Influenced by Baking Conditions and Oil Type." Eu ropean Food Research and Technology 236 p 843

- 51. Kroner, A and Marnet, N (2012) "Nicotiflorin, Rutin and Chlorogenic Acid: Phenylpropanoids Involved Differently in Quantitative Resistance of Potato Tubers to Biotrophic and Necrotrophic Pathogens." Plant Physiology and Biochemistry : PPB / Societe Francaise de Physiologie Vegetale 57 p 23

- 31. Kruzmane, D; L., J; and levinsh, G (2002) "Effect of regurgitant from Leptinotarsa decemlineata on wound responses in Solanum tuberosum and Phaseolus vulgaris." Phy siologia Plantarum. 115 (4): p 577

- 84. http://www.scopus.com/inward/record.url?eid=2

- s2.0

- 0036342399&partnerID=40&md5=c0bfa3b49a 7dc138c0360ce6829a202e

. Larkin, RP (2003) "Characterization of Soil Microbial Communities under Different Potato Cropping Systems by Microbial Population Dynamics, Substrate Utilization, and Fatty Acid Profiles." Soil Biology and Biochemistry. 35 (1451

- 146 6). Larkin, RP and Honeycutt, CW (2006) "Effects of Different 3

- Year Cropping Systems on Soil Microbial Communities and Rhizoctonia Diseases of Potato." Phytopathology. 96 p 68

- 79. Llorente, B; Alonso, GD; Bravo

- Almonacid, F; Rodriguez, V; Lopez, MG; Car rari, F; Torres, HN; and Flawia, Mm (2011) "Safety Assessment of Nonbrowning Potatoes: Opening the Discussion about the Relevance of Substantial Equivalence on Next Generation Biotech Crops." Plant Biotechnology Journal. 9 p 136

- 50. Love, SL (1994) "Ecolo gical Risk of Growing Transgenic Potatoes in the United States and Canada." American Potato Journal. (94713): p 647

- 58. Lovett, S; Price, P; and Lovett, J (2003) Managing riparian lands in the cotton industry . Narrabri, NSW: Cotton Research and Developmen t Corporation. Lundgren, JG and Duan, JJ (2013) "RNAi

- Based Insecticidal Crops: Potential Effects on Nontarget Species." BioScience. 63 p 657

- 65. Lyon, GD (1989) "The Biochemical Basis of Resistance of Potatoes to Soft Rot Erwinia spp.

-- a Review." Plant Pathology. 38 (3): p 313

- 39. Marinette County, W (2014) "Whitetail deer damage in Marinette County." http://www.marinettecounty.com/departments/page_e75ad7f9fb18/?department=a67be5f0c0 3a&subdepartment=c5c7ed67d63e

. Martinez, MV and Whitaker, JR (1995) "The Biochemistry and Control of Enzymatic Browning." Trends in Food Science & Technology. 6 p 195

- 200.

96Martins, SIFS; Jongen, WMF; and van Boekel, MAJS (2000) "A review of Maillard reaction in food and implications to kinetic modelling." Trends in Food Science & Technology. 11 (9

– 10): p 364

- 73. http://www.sciencedirect.com/science/article/pii/S092422440100022X

. Mayer, AM (2006) "Polyphenol oxidases in plants and fungi: Going places? A review." Phytochemistry. 67 (21): p 2318

- 31. http://www.ncbi.nlm.nih.gov/pubmed/16973188 http://www.scopus.com/inward/record.url?eid=2

- s2.0

- 33749517866&partnerI D=40&md5=0d679d8f3b4e90a165674171fbeee3a1

. McCray, K (2009) "Ground Water: Out of Sight, But Not Out of Mind." http://www.ngwa.org/public/awarenessweek/awareeditorial.aspx

. McDona ld, SK; Hofsteen, L; and Downey, L (2003) "Crop Profile for Potatoes in Colorado." Colorado State University. http://www.ipmcenters.org/cropprofiles/docs/copotatoes.pdf

. Mignery, GA; Pikaard, CS; and Park, WD (1988) "Molecular Characterization of the Patatin Multigene Family of Potato." Gene. 62 p 27

- 44. Mondy, N; Chandra, S; and Evans, W (1985) "Enzymatic discoloration and phenolic content of potato tubers from cultivars resistant and susceptible to the golden nematode." American Potato Journal. 62 (5): p 207

- 13. http://dx.doi.org/10.1007/BF02852799

. Moore, A and Olsen, N (No Date) "Organic Potato Production and Storage ." University of Idaho. http://www.extension.uidaho.edu/nutrient/pdf/OlsenMoore%20organic%20proc%202010.pdf

. Mossler, MA and Hutchinson, C (2011) "Florida C rop/Pest Management Profile: Potatoes." University of Florida IFAS Extension. http://edis.ifas.ufl.edu/pi030

. Mottram, DS; Wedzicha, BL; and Dodson, AT (2002) "Acrylamide is formed in the Maillard reaction." N ature. 419 (6906): p 448

- 49. http://www.nature.com/nature/journal/v419/n6906/pdf/419448a.pdf

. Muenscher, WC (1980) Weeds . New York and London: Cornell University Press. NBII ( 2010) "United States Regulatory Agencies Unified Biotechnology Website " http://usbiotechreg.nbii.gov/

. NCAT. "NCAT's Organic Crops Workbook: A Guide to Sustainable and Allowed Practices." National Center for Appropriate Technology, 2003. http://www.attra.org/attra

- pub/PDF/cropsworkbook.pdf

. Nolan, BT; Hitt, KJ; and Ruddy, BC (2002) "Probability of Nitrate Contamination of Recently Recharged G roundwaters in the Conterminous United States." Evironmental Science and Technology. 36 (10): p 2138

- 45. Non

- GMO

- Project (2010) "Non

- GMO Project Working Standard." http://www.nongmoproject.org/wp

content/uploads/2009/06/NGP

- Standard

- v7.pdf

. NPC (2012) "National Potato Council 2012 Statistical Yearbook." National Potato Council. NRC (2004) "Safety of Genetically Engineered Foods: Approaches to Assessing Unintended H ealth Effects." National Resource Council. http://www.nap.edu/openbook.php?record_id=10977&page=R1

. NSF (2011) "The NSF Potato Genome Project." National Science Foundation. www.potatogenome.berkeley.edu/nsf5/potato_biology/reroduction.php

. NTP (2011) "Report on Carcinogens

. " U.S. Department of Health and Human Services, Public Health Service. Last Accessed: July 8, 2013 http://ntp.niehs.nih.gov/ntp/roc/twelfth/roc12.pdf

. O'Brien, JM (2005) "Techniques to Cont rol the Damage by Voles." Internet Center for Wildlife Damage. Last Accessed: February 5, 2014 http://icwdm.org/handbook/rodents/voles.asp

. OECD (1997) "Consensus Document on the Biology of Solanu m tuberosum subsp. turberosum (Potato)." Olsen, N (2010) "Storage." Commercial Potato Production in North America: the Potato Association of America Handbook . Potato Association of America. p 81

- 82.

97Olsho, L and Fernandes, M (2013) "Relationship of White Potato to Other Vegetable Consumption by Schoolchildren and Adolescents in the USA: National Health and Nutrition Examination Survey, 2003

- 2008." Public Health Nutrition. 16 (11): p 1933

- 36. Organic Monitor. "Research Publication #7002

- 40. The Global Mar ket for Organic Food and Drink: Business Opportunities and Future Outlook." 2006. http://www.organicmonitor.com/700240.htm

. Organic Trade Association (2011) "Industry Statistics and Projected Growth. " http://www.ota.com/organic/mt/business.html?printable=1

. Osman, H; Youssef, M; El

- Gindi, A

- E

- M; Ameen, H; and Abd

- Elbary, N, Lashein, A. (2012) "Effect of reniform nematode, Rotylenc hulus reniformis , as biotic inducer of resistance against root

- knot nematode, Meloidogyne incognita in potato." Journal of Plant Protection Research. 52 (3): p 333

- 36. PAA (2009a) "Russet Burbank." Potato Association of America. www.potatoassociation.org/Industry%20Outreach/varieteis/Russets/russet_burbank.html

. PAA (2009b) "Varieties

-- Atlantic." Potato Association of America. www.potatoassociation.org/Industry%20Outreach/varieties/White%20Rounds/atlantic.html

. Painter, K; Miller, J; and Olsen, N (2010) "Costs and Returns for Irrigated Organic Ru sset Burbank Potato Production in Southern Idaho." University of Idaho. http://www.cals.uidaho.edu/edComm/pdf/BUL/BUL0876.pdf

. Pallais, N (1987) "True Potato Seed Quality." Theoretical a nd Applied Genetics. 73 p 783

- 92. Partington, JC; Smith, C; and G. P. Bolwell, GP (1999) "Changes in the location of polyphenol oxidase in potato (Solanum tuberosum L.) tuber during cell death in response to impact injury: Comparison with wound tissue." Planta. 207 (3): p 449

- 60. http://www.ncbi.nlm.nih.gov/pubmed/9951737

. Patterson, P (2010) "Costs of Production." Commercial Potato Production in North America: the Potato Association of America Ha ndbook . Potato Association of America. p 19

- 20. Patterson, P (2011) "2011 Cost of Potato Production Comparison for Idaho Commercial Potato Production." University of Idaho. http://web.cals.uidaho.edu/idahoagbiz/files/2013/01/2011CostofDec82011.pdf

. Pavek, W; Corsini, D; Love, SL; Hane, DC; Holm, DG; Iritani, WM; James, SR; Martin, MW; Mosley, AR; Ojala, JC; Stanger, CE; and Thonton, RE (1992) "Ranger Rsset: a Long Russet Potato Variety for Processing and Fresh Market with Improved Quality, Disease Re sistance, and Yield." American Potato Journal. 69 p 483

- 88. Pedreschi, F (2009) "Acrylamide Formation and Reduction in Fried Potatoes." Processing Effects on Safety and Quality of Foods . p 231

- 51. Plaisted, RL (1980) "Potato." Hybridization of Crop Plant s . Madison, Wisconsin. p 483

- 94. Plissey, ES and Erhardt, WH (2000) "Growing Potatoes." University of New Hampshire. http://extension.unh.edu/resources/files/resource000606 _rep628.pdf

. Preston, D (2010) "Potato Bruising." Commercial Potato Production in North America: the Potato Association of America Handbook . Potato Association of America. p 77

- 80. Radcliffe, EB (2010) "Insect Control." Commercial Potato Production in Nor th America: the Potato Association of America Handbook . Potato Association of America Handbook. p 64

- 67. Reuters (2001) "Morinaga Recalls Potato Snack Over GM Concerns." http://www.gene.ch/ge net/2001/Jul/msg00047.html

. Roberts, W and Cartwright, B (No Date) "Potato Production." Oklahoma State University. http://pods.dasnr.okstate.edu/docushare/dsweb /Get/Document

- 1506/HLA

- 6028web.pdf

.

98Robertson, GP and Swinton, SM (2005) "Reconciling agricultural productivity and environmental integrity: A grand challenge for agriculture." Frontiers in Agriculture and the Environment. 3 p 38

- 46. Ronald, P and Fouche, B (2006) "Genetic Engineering and Organic Production Systems." http://ucanr.org/freepubs/docs/8188.pdf

. Rondon, SI (2012) "Pest Management Strategies for Potato Insect Pests in t he Pacific Northwest of the United States." Insecticides

-- Pest Engineering . p 309

- 33. Rosen, C (2010a) "Building Up Soil Organic Matter Content." Commercial Production of Potatoes in North America: the Potato Association of America Handbook . Potato Associ ation of America. p 36. Rosen, C (2010b) "Growth Requirements of the Potato." Commercial Potato Production in North America: the Potato Association of America Handbook . Potato Association of America. p 32. Rosen, C (2010c) "Soil Requirements." Commercial Production of Potato in North America: the Potato Association of America Handbook . Potato Association of America. p 32. Rosen, C (2010d) "Temperature and Moisture." Commercial Potato Production in North America: the Potato Association of America Handbook . Potato Association of America. p 33. Saini, GR and Grant, WJ (1980) "Long

- Term Effects of Intensive Cultivation on Soil Quality in the Potato

Growing Areas of New Brunswick (Canada) and Maine (U.S.A.)." Canadian Journal of Soil Science. 60 p 421

- 28. Sc iences, NAo (2004) "Safety of Genetically Engineered Foods: Approaches to Assessing Unintended Health Effects." National Academy of Sciences. Senseman, SA (2007) Herbicide Handbook, Ninth Edition . Ed. Senseman, S.A.: Weed Science Society of America. Sext on, P (2010) "Soil Preparation." Commercial Potato Production in North America: the Potato Association of America Handbook . Potato Association of America. p 35

- 36. Sharp, PA (2001) "RNA Interference: 2001." Genes & Development. 15 (5): p 485

- 90. http://genesdev.cshlp.org/content/15/5/485.short

. Shock, C (2010) "Water Requirements and Irrigation." Commercial Potato Production in North America: the Potato Association of America Handbook . Potato Association of America. p 54

- 56. Sieczka, J (2010) "Cultivation." Commercial Potato Production in North America: the Potato Association of America Handbook . Potato Association of America Handbook. p 53. Simplot (2013a) "Environmental Report for Petition for Determination of Nonregulated Status for Innate Potatoes." JR Simplott Company. Simplot (2013b) "Petition for Determination of Nonregulated Status for Innate Potatoes with Low Acrylamide Potential and Reduced Black Spot Bruise: Events E12 and E24 (Ru sset Burbank); F10 and F37 (Fanger Russet); J3, J55, and J78 (Atlantic); G11(G); H37 and H50 (H) " J.R. Simplot Company. http://www.aphis.usda.gov/biotechnology/petitions _table_pending.shtml

. Sinden, SL (1987) "Potato Glycoalkaloids." Acta Horticulturae. 207 p 41

- 47. Skaggs, RW; Breve, MA; and Gilliam, JW (1993) "Hydrologic and Water Quality Impacts of Agricultural Drainaged." Critical Reviews in Food Science and Technolo gy. 24 (1): p 1

- 32. Souba, WW (1991) "Glutamine: a Key Substrate for the Splanchic Bed." Annual Review of Nutrition. 11 p 285

- 308. Southwood, T and Way, M (1970) "Ecological background to pest management." Concepts of Pest Management . Raleigh: N.C. State University. p 7

- 28. Spooner, D (2010) "Plant Introduction and Maintenance." Commercial Potato Production in North America: the Potato Association of America Handbook . Potato Association of America. p 7.

99Spooner, DM; van den Berg, RG; Rodriguez, A; Bamberg, J; Hijmans, RJ; and Lara Cabrera, SI (2004) "Wild Potatoes (Solanum Section Petota: Solanaceae) of North and Central America." Systematic Botany Monographs. 68 p 1

- 209. Stadler, RH; Blank, I; Varga, N; Robert, F; Hau, J; Guy, PA; Robert, M

- C; and Riediker, S (2002) "Acrylamide from Maillard reaction products." Nature. 419 (6906): p 449

- 50. http://www.scopus.com/inward/record.url?eid=2

- s2.0

- 0037015502&partnerID=40&md5=d57778e14d3c7881da9c8b3b8347804e

. Steffens, JC (1994) "Polyphenol Oxidase." Genetic Engineering of Plant Secondary Metabolism . New York: Plenum Press. p 275

- 312. S tremmel, N; Praeger, U; Konig, C; Fehrle, I; Erban, A; Geyer, M; Kopka, J; and van Dongen, JT (2010) "Time Course Effects on Primary Metabolism of Potato (Solanum tuberosum) Tuber Tissue after Mechanical Impact." Postharvest Biology and Technology. 56 p 10 9

- 16. Tareke, E; Rydberg, P; Karlsson, P; Eriksson, S; and Törnqvist, M (2002) "Analysis of Acrylamide, a Carcinogen Formed in Heated Foodstuffs." Journal of Agricultural and Food Chemistry. 50 (17): p 4998

- 5006. http://www.scopus.com/inward/record.url?eid=2

- s2.0

- 0037077394&partnerID=40&md5=fc851ac1c9071cf0169807d9daaec757

. Taylor, R (2014) "The Feral Hog in Texas." Texas Parks an d Wildlife Department. Last Accessed: February 4, 2014 http://www.tpwd.state.tx.us/huntwild/wild/nuisance/feral_hogs/

. Thygesen, PW; Dry, IB; and Robinson, SP (1995) "Polyphenol oxidase in potato. A multigene family that exhibits differential expression patterns." Plant Physiology. 109 (2): p 525

- 31. http://www.plantphysiol.org/content/109/2/525.full.pdf

. Tran , LT; Taylor, JS; and Constabel, CP (2012) "The Polyphenol Oxidase Gene Family in Land Plants: Lineage

- specific Duplication and Expansion." BMC Genomics. 13 p 395. Urbany, C; Colby, T; Stich, B; Schmidt, L; Schmidt, J; and Gebhardt, C (2012) "Analysis of Natural Variation of the Potato Tuber Proteome Reveals Novel Candidate Genes for Tuber Bruising." Journal of Proteome Research. 11 p 703

- 16. Urbany, C; Stich, B; Simon, L; Berding, H; Junghans, H; Niehoff, K

- H; Braun, A; Tacke, E; Hofferbert, H

- R; Lubek, J; Strahwald, J; and Gebhardt, C (2011) "Association Genetics in Solanum tuberosum Provides New Insights into Potato Tuber Bruising and Enzymatic Tissue Discoloration." BMC Genomics. 12 (7): p 1

- 14. US

- EPA (2000) "Profile of the Agricultural Crop Product ion Industry." U.S. Environmental Protection Agency

- Office of Compliance Sector Notebook Profile. http://www.epa.gov/compliance/resources/publications/assistance/sectors/notebooks/agcrop. pdf

. US

- EPA (2003) "National Management Measures to Control Nonpoint Source Pollution from Agriculture

. " http://water.epa.gov/polwaste/nps/agriculture/agmm_index.cfm

. US

- EPA (2005) "Protecting Water Quality from Agricultural Runoff." US

- EPA (2009a) "National Water Quality Inventory: Report to Congress." US

- EPA (2009b) "Pesticide Spray and Du st Drift." U.S. Environmental Protection Agency. http://www.epa.gov/opp00001/factsheets/spraydrift.htm

. US

- EPA (2011a) "Clean Air Act (CAA)." www.epa.gov/agriculture/lcaa.html

. US

- EPA (2011b) "Idaho Nonattainment Area Plans." http://yosemite.epa.gov/r10/airpage.nsf/283d45bd5bb068e688256 50f0064cdc2/e2ab2cc6

. US

- EPA (2011c) "Introduction to Biotechnology Regulation for Pesticides." www.epa.gov/oppbppd1/biopesticides/regtools/biotech

- reg
- prod.htm

. US

- EPA (2011d) "Pesticides: Registration Review." U.S. Environmental Protection Agency. http://www.epa.gov/oppsrrd1/registration_review/

. 100US

- EPA. "Sole Source Aquifer Protection Program." 2011e. http://water.epa.gov/infrastructure/drinkingwater/sourcewater/protection/solesourceaquifer.c fm >. US

- EPA (2012a) "Inventory of U.S. Greenhouse Gas Emissions and Sinks: 1990

- 2010." US

- EPA. http://www.epa.gov/climatechange/Downloads/ghgemissions/US

- GHG

- Inventory

- 2012

- Main

Text.pdf

. US

- EPA (2012b) "Watershed Assessment, Tracking & Environmental Report. National Summary. Causes of Impairment in Assessed Rivers and Streams." http://iaspub.epa.gov/waters10/attains_index.control

. US

- FDA (2006) "Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non

- Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use." U.S. Food and Drug Administration. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Bi otechnology/ucm096156.htm

. US

- NARA (2010) "Executive Orders disposition tables index." Unite d States National Archives and Records Administration. http://www.archives.gov/federal

- register/executive

orders/disposition.html

. USDA

- AMS (2010) "National Organic Program." Agricultural Marketing Service United States Department of Agriculture. http://www.ams.usda.gov/AMSv1.0/nop USDA

- APHIS (2013a) "J.R. Simplot Company Petition (13

- 022

- 01p) for Determination of N on
- regulated Status of Low Acrylamide Potential and Reduced Black Spot Bruise Potato Events F10, F37, E12, E24, J3, J78, G11, H37, and H50: Plant Pest Risk Assessment." USDA

- APHIS. USDA

- APHIS (2013b) "Potato virus Y strains

. " Agriculture, United States De partment of. Last Accessed: September 12, 2013 http://www.aphis.usda.gov/plant_health/plant_pest_info/potato/pvy_main.shtml

. USDA

- APHIS (2013c) "Wisconsin Wildlife Damage Abatement and Claims Program

- 2012." Last Accessed: February 5, 2014 http://tremplocounty.com/landmanagement/2012%20W DACP%20Summary%20Report.pdf

. USDA

- APHIS (2014a) "All US Species." http://ecos.fws.gov/tess_public/pub/SpeciesReport.do

. USDA

- APHIS (2014b) "Listed Species in States with Commercial potato Production." http://ecos.fws.gov/tess_public/pub/SpeciesReport.do

. USDA

- APHIS (2014c) "Proposed Species in States where Potatoes are Commercially Grown." Last Accessed: February 19, 2014 USDA

- APHIS and USFWS (2012) "Memorandum of Understanding " p 1

- 14. USDA

- ERS. "Certified Organic Acreage of Other Crops by State, 2008." 2009. USDA

- ERS (2012a) "Potatoes." http://www.ers.usda.gov/topics/crops/vegetables

- pulses/potatoes.aspx

. USDA

- ERS (2012b) "Vegetables and Pulses Outlook." http://www.ers.usda.gov/publications/vgs

vegetables

- and

- pulses

- outlook/vgs

- 349.aspx

. USDA

- ERS (2013) "Vetables and Pulses Data." http://www.ers.usda.gov/data

- products/vegetables

- and

pulses

- data/data

- by

- commodity

- imports

- and

exports.aspx?reportPath=/TradeR3/TradeTables&programArea=veg&stat_year=2007&top=5&H ardCopy=True&RowsPerPage=25&groupName=Vegetables&commodityName=Potatoes#P182b 5a9620b445baa8f47d4e33f25793_6_652

. USDA

- NASS "Census of Agriculture." http://www.nass.usda.gov/Quick_Stats/

. USDA

- NASS "Census of Agriculture." http://www.nass.usda.gov/Quick_Stats/

. USDA

- NASS (2012a) "2011 Certified Org anic Production Survey." USDA

- NASS.

101USDA

- NASS. "Acreage." Washington, DC: National Agricultural Statistics Service, Agricultural Statistics Board, USDA, 2012b. 42. http://www.usda.gov/nas s/PUBS/TODAYRPT/acrg0612.pdf

. USDA

- NASS "QuickStats Ad

- hoc Query Tool." USDA National Agricultural Statistical Service. http://www.nass.usda.gov/Quick_Stats/

. USDA

- NASS (2013a) "Potatoes 2012 Summary." http://usda01.library.cornell.edu/usda/current/Pota/Pota

- 09

- 19

- 2013.pdf

. USDA

- NASS (2013b) "USDA Census of Agriculture Quick Stats." http://www.nass.usda.gov/Quick_Stats/

. USDA

- NRCS (1999) "Soil Taxonomy: A Basic System of Soil Classification for Making and Interpreting Soil Surveys." U.S. Department of Agriculture

– Natural Resources Conservation Service. http://soils.usda.gov/technical/classification/taxonomy/

. USDA

- NRCS (2001) "Soil Quality

- Introduction." U.S. Department of Agriculture

– Natural Resources Conservation Service. http://soils.usda.gov/sqi/publications/publications.html#agy

. USDA

- NRCS (2004) "Soil Biology and Land Management." U.S. Department of Agriculture

– Natural Resources Conservation Service. http://soils.usda.gov/sqi/publications/publications.html#atn

. USDA

- NRCS (2006) "Conservation Resource Brief: Soil Quality." U.S. Department of Agriculture

– Natural Resources Conserva tion Service. https://prod.nrcs.usda.gov/Internet/FSE_DOCUMENTS/nrcs143_023219.pdf. USDA

- NRCS (2010) "Keys to Soil Taxonomy." U.S. Department of Agriculture

– Natural Resources Conservation Service. http://soils.usda.gov/technical/classification/tax_keys/

. USDA

- NRCS "PLANTS Database: Plants profile for Solanum fendleri A. Gray ex Torr. (Fendler's horsenettle)." United States Department of Agriculture, Natural Resources Conservation Servi ce. Last Accessed: September 12, 2013 http://plants.usda.gov/core/profile?symbol=SOFE

. USDA

- NRCS "PLANTS Database: Plants profile for Solanum jamesii Torr." United States Department of Agricul ture, Natural Resources Conservation Service. Last Accessed: September 12, 2013 http://plants.usda.gov/core/profile?symbol=SOJA

. USDA

- NRCS (2014) "Introduced, Invasive and Noxious Plants." htt ps://plants.usda.gov/java/noxComposite. USDA (2000) "Crop Profile for Potatoes in North Dakota." www.ag.ndsu.nodak.edu/aginfo/entomology/ndpiap/ND_Crop_Profi les/Potato/crop

. USDA (2012) "USDA Agricultural Projections to 2021." USFWS (1983) "The Revised Columbian White

- tailed Deer Recovery Plan." USFWS. Last Accessed: February 20, 2014 http://ec os.fws.gov/docs/recovery_plan/830614.pdf

. USFWS (1991) "Hualapai Mexican Vole Recovery Plan " Last Accessed: February 20, 2014 http://ecos.fws.gov/docs/recovery_plan/910819.pdf

. USFWS (2011) "Draft Environmental Assessment

- Use of Genetically Modified, Glyphosate

- Tolerant Soybeans and Corn on National Wildlife Refuge Lands in the Mountain

– Prairie Region (Region 6)." U.S. Fish and Wildlife Service. http://www.fws.gov/mountain

prairie/planning/resources/documents/resources_gmo_ea.pdf

. USFWS (2014a) "Environmental Conservation Online System." Last Accessed: February 18, 2014 http://ecos.fws.gov/tess_public/pub/SpeciesReport.do?groups=Q&listingType=L&mapstatus=1

. USFWS (2014b) "Species Profile for Amargosa Vole." USFWS. Last Accessed : February 20, 2014 http://ecos.fws.gov/speciesProfile/profile/speciesProfile.action?spcode=A082#lifeHistory

. USFWS (2014c) "Species Profile forKe y Deer." USFWS. Last Accessed: February 20, 2014 http://ecos.fws.gov/speciesProfile/profile/speciesProfile.action?spcode=A003

. USFWS (2014d) "Species Profiles Flor ida Salt Marsh Vole." USFWS. Last Accessed: February 20, 2014 http://ecos.fws.gov/speciesProfile/profile/speciesProfile.action?spcode=A0ET

.

102Vitti, MCD; Sasaki, FF; Miguel, P; Kluge, RA; and Moretti, CL (2011) "Activity of Enzymes Associated with the Enzymatic Browning of Minimally Processed Potatoes." Brazilian Archives of Biology and Technology. 54 (5): p 983

- 90. Wang, J; Chen, L; Li, P; Li, X; Zhou, H; Wang, F; L i, D; Yin, Y; and Wu, G (2008) "Gene Expression Is Altered in Piglet Small Intestine by Weaning and Dietary Glutamine Supplementation." The Journal of Nutrition. 138 p 1025

- 32. WHO

- IARC (1994) "IARC monographs on the evaluation of carcinogenic risks to hu mans: some industrial chemicals

. " Cancer, International Agency for Research on. http://monographs.iarc.fr/ENG/Monographs/vol60/

. Wilson, EO (1988) Biodiversity . Washington, DC: National Academ y Press. Yoruk, R and Marshall, MR (2003) "Physicochemical Properties and Function of Plant Polyphenol Oxidase: a Review." Journal of Food Biochemistry. 27 p 361

- 422. Zapiola, ML; Campbell, CK; Butler, MD; and Mallory

- Smith, CA (2008) "Escape and establi shment of transgenic glyphosate

- resistant creeping bentgrass Agrostis stolonifera in Oregon, USA: a 4

- year study." Journal of Applied Ecology. 45 (2): p 486

- 94. http://dx.doi.org/10.1111/j. 1365

- 2664.2007.01430.x

. Zebarth, BJ; Paul, JW; and Van Kleeck, R (1999) "The Effect of Nitrogen Management in Agricultural Production on Water and Air Quality: Evaluation on a Regional Scale." Agriculture, Ecosystems and Environment. 72 p 35

- 52.

103